Terminated

Package of cross-drive bone screws labeled in part: "REF #95-1504"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK1.5 X4MM TITANIUMCAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIANBIOMET MICROFIXATION1520 TRADEPORT DRIVEJACKSONVILLE, FL 32218 USAwww.biometmicrofixation.com" "REF: 91-1504"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW1.5 X4MM TITANIUMCAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.BIOMET MICROFIXATION1520 TRADEPORT DRIVEJACKSONVILLE, FL 32218 USAwww.biometmicrofixation.com" Products subject to recall: REF #95-1504"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK, Lot 622120. REF: 91-1504"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK, Lot 622120. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

FDA Recall Z-0835-2012 · Posted 2012-01-23

Recalling FirmBiomet Microfixation, Inc.

Recall StatusTerminated

Product CodeNDJ

Date Initiated2010-11-08

Date Terminated2012-01-31

Product Quantity295

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

Firm Action

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

Distribution Pattern

Worldwide Distribution - USA including CA, GA, OH, TX, and VA and the countries of S Africa and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953385LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEMWalter Lorenz Surgical, Inc. · 1995-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.