Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem… recallZ-0178-2010 · Zimmer Inc. · initiated Sep 17, 2009
Terminated All recalls posted in November 2009
Is my device affected?
- 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.
- 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.
- 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
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
FDA root cause category: Other
What the company is doing
Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
Recall details
- Recall number
- Z-0178-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 17, 2009
- Posted by the FDA
- Nov 12, 2009
- Recalling firm
- Zimmer Inc.
- Quantity
- 12
- Product code
- HSD
- FDA submissions
- K041549
- Distribution
- Nationwide.
Product description
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.
Code information (models, lots, serial numbers)
Lot 60947164.
Other devices under the same FDA submission
1 device cleared under K041549 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trabecular Metal® 4342-110-13Zimmer, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 53536).
- Z-0177-2010 · TerminatedZimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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