Trabecular Metal acetabular revision system buttress… recallZ-2215-2010 · Zimmer Inc. · initiated Apr 6, 2010
Terminated All recalls posted in August 2010
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
The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
FDA root cause category: Packaging
What the company is doing
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
Recall details
- Recall number
- Z-2215-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 6, 2010
- Posted by the FDA
- Aug 12, 2010
- Recalling firm
- Zimmer Inc.
- Quantity
- 1972 all products
- Product code
- LPH
- FDA submissions
- K061067
- Distribution
- US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
Product description
Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
Code information (models, lots, serial numbers)
60492195, 60531077, 60530963, 60661414, 60712297, 60770942, 60796674, 60834367, 60990646 and 61324530.
Other devices under the same FDA submission
2 devices cleared under K061067 — 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™ 00-4894-300-00Zimmer Trabecular Metal Technology Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- TRABECULAR METAL™ 00-4894-400-00Zimmer Trabecular Metal Technology Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 55364).
- Z-2214-2010 · TerminatedTrabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address b…
- Z-2216-2010 · TerminatedTrabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that a…
- Z-2217-2010 · TerminatedTrabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ.
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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