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Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length… recallZ-1344-06 · Zimmer Inc. · initiated Jun 26, 2006

Terminated All recalls posted in August 2006

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 Zimmer 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

Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

FDA root cause category: Other

What the company is doing

Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.

Recall details

Recall number
Z-1344-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 26, 2006
Posted by the FDA
Aug 3, 2006
Recalling firm
Zimmer Inc.
Quantity
310 total for all catalog numbers
Product code
HWC
FDA submissions
K934765
Distribution
Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.

Product description

Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6250-65-20 (00625006520).

Code information (models, lots, serial numbers)

Lot 60330168.

Other devices under the same FDA submission

8 devices cleared under K934765 — 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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