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Biomet Microfixation Temporomandibular Joint (TMJ) Patient… recallZ-2566-2014 · Biomet Microfixation, LLC · initiated Sep 20, 2013

Class II Terminated All recalls posted in September 2014

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, LLC 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

Product mix occurred prior to final package and labeling process.

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

What the company is doing

Biomet Microfixation, Inc. sent an Urgent Medical Device Field Notice dated September 20, 2013 to its customer. The customer was instructed to: 1) Immedicately quarantine the device. 2) Discontinue use and return to Biomet Microfixation. 3) If the product was further distributed, the letter must be forwarded to the firm's customers. 4) A replacement device will be shipped priority upon completion. Questions related to this notice should be directed to 904-741-9448 or 904-239-6671. For questions regarding this recall call 904-741-4400.

Recall details

Recall number
Z-2566-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 20, 2013
Posted by the FDA
Sep 2, 2014
Recalling firm
Biomet Microfixation, LLC
Quantity
1
Product code
LZD
FDA submissions
P020016
Distribution
Worldwide Distribution to Denmark only.

Product description

Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.

Code information (models, lots, serial numbers)

Part #CP751506 Lot #478490

Other devices under the same FDA submission

30 devices cleared under P020016 — 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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