Depuy brand Acclaim Elbow linked ulnar bearing assembly… recallZ-0531-06 · Depuy Orthopaedics, Inc. · initiated Nov 8, 2005
Terminated All recalls posted in February 2006
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 Depuy Orthopaedics, 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 ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
FDA root cause category: Other
What the company is doing
Consignees were notified via letter dated 11/10/05 and asked to return product.
Recall details
- Recall number
- Z-0531-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 8, 2005
- Posted by the FDA
- Feb 16, 2006
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product code
- JDB
- FDA submissions
- K992656
- Distribution
- Nationwide, Argentina, Ireland, New Zealand and Spain.
Product description
Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.
Code information (models, lots, serial numbers)
All units.
Other devices under the same FDA submission
1 device cleared under K992656 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ACCLAIM 1722-85-000Depuy Orthopaedics, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 34018).
- Z-0530-06 · TerminatedDepuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000.
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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