Medical Device Recall #29391 | Medicaldevicehub

CFRES ID:	92305
Device Name:	N/A
Product RES Number:	Z-2206-2010
Event Date Initiated:	2010-03-17
Event Date Posted:	2010-08-11
Event Date Created:	N/A
Event Date Terminated:	2010-08-11
Recall Status:	Terminated
Res Event Number:	54370
Product Code:	DZL
K Numbers:	["K953385"]
PMA Numbers:	N/A
Product Description:	BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Code Info:	Lot 148530
Recalling Firm:	Biomet Microfixation, Inc.
Firm FEI Number:	N/A
Adress 1:	1520 Tradeport Dr
Adress 2:	N/A
City:	Jacksonville
State:	FL
Postal Code:	32218-2480
Additional Contact Info:	904-741-4400
Reason for Recall:	Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
Root Cause Description:	Other
Other Submission Description:	N/A
Action:	Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.
Product Quantity:	1247 screws
Distribution Pattern:	Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-08-11
Device Class:	N/A
Open FDA:	{"k_number"=>["K182881", "K761228", "K031807", "K021522", "K960945", "K770131", "K083432", "K911165", "K012908", "K093464", "K021850", "K161857", "K103084", "K010690", "K981881", "K992623", "K063769", "K050535", "K181854", "K012486", "K980760", "K963546", "K974392", "K171831", "K201210", "K973056", "K080430", "K151540", "K100182", "K041887", "K993493", "K050515", "K160991", "K955140", "K982927", "K981459", "K092855", "K972480", "K982951", "K050606", "K964261", "K980199", "K981362", "K101902", "K993575", "K952167", "K981666", "K983728", "K093719", "K051871", "K132212", "K151195", "K022790", "K983485", "K002423", "K961418", "K951510", "K955369", "K073342", "K201561", "K911936", "K130682", "K993327", "K962774", "K910427", "K974817", "K010527", "K011675", "K973180", "K042573", "K002935", "K140908"], "registration_number"=>["3008812560", "3009551666", "1721676", "3015399803", "9614404", "1825034", "1287163", "3010165244", "1032347", "2431866", "3004927096", "1649518", "3014315560", "3011530718", "1000606483", "9610905", "3016750097", "3014615056", "3004730368", "3005846524", "3015212339", "3009417901", "3012187970", "3010596333", "3014540272", "1054986", "3011764595", "3003394081", "3012571693", "3009201148", "1828288", "3011302692", "3004049923", "2939274", "2245304", "8010516", "8010177", "1057946", "3017399129", "3022378059", "3015877656", "8043554", "3003139373", "3017980266", "3022426941", "9611367", "3003108161", "1060818", "2027148", "3004431266", "1650372", "3006540014", "1651260", "3006194679", "1719045", "3007923096", "8010099", "9613348", "3007738812", "3010197348", "2027754", "3008791302", "3021551875", "3006017180", "1226425", "3000270450", "2029275", "3008868758", "3013111980", "1066741", "3007515069", "3011196443", "3010363503", "3008261720", "3001239363", "3015869493", "3015440604"], "fei_number"=>["3008812560", "1000306431", "3009551666", "3002807318", "1721676", "3015399803", "1825034", "1287163", "3010165244", "1032347", "2431866", "3004927096", "3014315560", "3011530718", "1000606483", "1000592496", "3016750097", "3014615056", "3004730368", "3005846524", "3015212339", "3009417901", "3012187970", "3002821504", "3002807464", "3010596333", "3014540272", "3011764595", "3003394081", "3012571693", "3009201148", "1828288", "3011302692", "3004049923", "2939274", "3002807169", "3000136405", "2245304", "3017399129", "3022378059", "3015877656", "3003139373", "3017980266", "3022426941", "3003108161", "3001000014", "2027148", "3004431266", "3006540014", "1000525271", "5870", "3004169071", "3006194679", "1719045", "3004975279", "3007923096", "3007738812", "3010197348", "2027754", "3008791302", "3021551875", "3006017180", "3001236277", "3015440604", "3000270450", "3003005156", "3002253367", "3008868758", "3003018882", "3013111980", "3007515069", "3011196443", "3010363503", "3008261720", "3001239363", "3015869493", "1000114355"], "device_name"=>"Screw, Fixation, Intraosseous", "medical_specialty_description"=>"Dental", "regulation_number"=>"872.4880", "device_class"=>"2"}

CFRES ID:

92305

Device Name:

N/A

Product RES Number:

Z-2206-2010

Event Date Initiated:

2010-03-17

Event Date Posted:

2010-08-11

Event Date Created:

N/A

Event Date Terminated:

2010-08-11

Recall Status:

Terminated

Res Event Number:

54370

Product Code:

DZL

K Numbers:

["K953385"]

PMA Numbers:

N/A

Product Description:

BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

Code Info:

Lot 148530

Recalling Firm:

Biomet Microfixation, Inc.

Firm FEI Number:

N/A

Adress 1:

1520 Tradeport Dr

Adress 2:

N/A

City:

Jacksonville

State:

FL

Postal Code:

32218-2480

Additional Contact Info:

904-741-4400

Reason for Recall:

Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.

Root Cause Description:

Other

Other Submission Description:

N/A

Action:

Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.

Product Quantity:

1247 screws

Distribution Pattern:

Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-08-11

Device Class:

N/A

Open FDA:

{"k_number"=>["K182881", "K761228", "K031807", "K021522", "K960945", "K770131", "K083432", "K911165", "K012908", "K093464", "K021850", "K161857", "K103084", "K010690", "K981881", "K992623", "K063769", "K050535", "K181854", "K012486", "K980760", "K963546", "K974392", "K171831", "K201210", "K973056", "K080430", "K151540", "K100182", "K041887", "K993493", "K050515", "K160991", "K955140", "K982927", "K981459", "K092855", "K972480", "K982951", "K050606", "K964261", "K980199", "K981362", "K101902", "K993575", "K952167", "K981666", "K983728", "K093719", "K051871", "K132212", "K151195", "K022790", "K983485", "K002423", "K961418", "K951510", "K955369", "K073342", "K201561", "K911936", "K130682", "K993327", "K962774", "K910427", "K974817", "K010527", "K011675", "K973180", "K042573", "K002935", "K140908"], "registration_number"=>["3008812560", "3009551666", "1721676", "3015399803", "9614404", "1825034", "1287163", "3010165244", "1032347", "2431866", "3004927096", "1649518", "3014315560", "3011530718", "1000606483", "9610905", "3016750097", "3014615056", "3004730368", "3005846524", "3015212339", "3009417901", "3012187970", "3010596333", "3014540272", "1054986", "3011764595", "3003394081", "3012571693", "3009201148", "1828288", "3011302692", "3004049923", "2939274", "2245304", "8010516", "8010177", "1057946", "3017399129", "3022378059", "3015877656", "8043554", "3003139373", "3017980266", "3022426941", "9611367", "3003108161", "1060818", "2027148", "3004431266", "1650372", "3006540014", "1651260", "3006194679", "1719045", "3007923096", "8010099", "9613348", "3007738812", "3010197348", "2027754", "3008791302", "3021551875", "3006017180", "1226425", "3000270450", "2029275", "3008868758", "3013111980", "1066741", "3007515069", "3011196443", "3010363503", "3008261720", "3001239363", "3015869493", "3015440604"], "fei_number"=>["3008812560", "1000306431", "3009551666", "3002807318", "1721676", "3015399803", "1825034", "1287163", "3010165244", "1032347", "2431866", "3004927096", "3014315560", "3011530718", "1000606483", "1000592496", "3016750097", "3014615056", "3004730368", "3005846524", "3015212339", "3009417901", "3012187970", "3002821504", "3002807464", "3010596333", "3014540272", "3011764595", "3003394081", "3012571693", "3009201148", "1828288", "3011302692", "3004049923", "2939274", "3002807169", "3000136405", "2245304", "3017399129", "3022378059", "3015877656", "3003139373", "3017980266", "3022426941", "3003108161", "3001000014", "2027148", "3004431266", "3006540014", "1000525271", "5870", "3004169071", "3006194679", "1719045", "3004975279", "3007923096", "3007738812", "3010197348", "2027754", "3008791302", "3021551875", "3006017180", "3001236277", "3015440604", "3000270450", "3003005156", "3002253367", "3008868758", "3003018882", "3013111980", "3007515069", "3011196443", "3010363503", "3008261720", "3001239363", "3015869493", "1000114355"], "device_name"=>"Screw, Fixation, Intraosseous", "medical_specialty_description"=>"Dental", "regulation_number"=>"872.4880", "device_class"=>"2"}

Detailed Result for Z-2206-2010