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Package of center-drive bone screws labeled in part:… recallZ-0836-2012 · Biomet Microfixation, Inc. · initiated Nov 8, 2010

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet Microfixation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-0836-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 8, 2010
Posted by the FDA
Jan 23, 2012
Recalling firm
Biomet Microfixation, Inc.
Quantity
484
Product code
NDJ
FDA submissions
K953385
Distribution
Worldwide Distribution - USA including CA, GA, OH, TX, and VA and the countries of S Africa and Japan

Product description

Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 99-7204***"1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" REF: 01-7204 1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG, Lot 202450. REF: 99-7204 "1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG, Lot 202450. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

Code information (models, lots, serial numbers)

Lot # 202450

Other devices under the same FDA submission

41 devices cleared under K953385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 59181).

Sources and updates

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