FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000.
- Recall number
- Z-0530-06
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000.
- Status
- Terminated
- Initiated
- 2005-11-08
- Posted
- 2006-02-16
- Terminated
- 2006-06-16
- Reason
- The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 11/10/05 and asked to return product.
- Quantity
- not on file
- Distribution
- Nationwide, Argentina, Ireland, New Zealand and Spain.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K992656"]
- PMA numbers
- not on file
- Product code
- JDB
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28