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Oss Interlok Bowed Im Stem W/Screw 14 Mm X 150 Mm Ti 6al 4v… recallZ-0417-2012 · Biomet, Inc. · initiated Nov 1, 2011

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, 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

Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).

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

What the company is doing

Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.

Recall details

Recall number
Z-0417-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 1, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
Biomet, Inc.
Quantity
3 units & 1 pending release
Product code
KRO
FDA submissions
K002757
Distribution
Distributed only in The Netherlands.

Product description

OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.

Code information (models, lots, serial numbers)

Item: 150368; Lot 081650

Other devices under the same FDA submission

59 devices cleared under K002757 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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