Package of cross-drive bone screws labeled in part: "REF #95-1504"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

FDA device recall Z-0835-2012 · posted 2012-01-23 · Terminated

Recall details

Recalling firm: Biomet Microfixation, Inc.
Reason for recall: On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes
Action taken: Biomet Microfixation, Jacksonville, FL, sent an Urgent Medical Device Safety Alert letter dated November 8, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX to 904-741-9425. If consignees further distributed this product, they must notify the recipient of this action by providing the recipient a copy of the notice. For questions call 800-874-7711 or 904-741-4400, ext 468.
Root cause: Mixed-up of materials/components
Status: Terminated
Product code: NDJ
Quantity affected: 295
Distribution: Worldwide Distribution - USA including CA, GA, OH, TX, and VA and the countries of S Africa and Japan
Date initiated: 2010-11-08
Date posted: 2012-01-23
Date terminated: 2012-01-31
Location: Jacksonville, FL

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM (K953385)	Walter Lorenz Surgical, Inc.	1995-09-28