FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy LCS Complete RP insert; polyethylene tibial insert STD+, 10 mm; Ref 1294-05-510.
- Recall number
- Z-1126-05
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy LCS Complete RP insert; polyethylene tibial insert STD+, 10 mm; Ref 1294-05-510.
- Status
- Terminated
- Initiated
- 2005-05-26
- Posted
- 2005-08-12
- Terminated
- 2005-12-02
- Reason
- An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Root cause
- Other
- Action
- not on file
- Quantity
- 774
- Distribution
- Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
- Lot, serial or model codes
- Lots X16CA4, X1BC94, X1BDF4, X1BDG4, X1BDN4, X1BDR4, X2XBA4, X2XBC4, X2XBK4, X2XBL4, X2XBM4, X4TB34, X4TBG4, X4TBL4, Y3BC64, Y3BC74, Y3BCJ4, Y3BDG4, Y3GH74, Y4AHJ4, Y4RE84, Y4RE94, Y4RFF4, Y4RFJ4, Y4RFL4, Y4RFT4, Y4RFV4, Y4RFX4, Y5C114, Y5C124, Y5C134, Y5C164, Y5C1D4, Y5C1K4, Y5C1M4, Y5C1P4, YC1B34, YC1BE4, YD2D24, YE5B34, YE5B64, YE5B94, YE5BT4, YE5BW4, YE5CA4, YE5CC4, YE5CM4, YE5CP4, YE5CT4, YL3BA4, YL3BB4, YN1CE4, YP5B14, YP5B34, YP5B54, YP5CE4, YP5CF4, YP5CG4, YP5CH4, YP5CL4, YP5CN4, YP7C14, YP7CF4, YP7CL4, YP7CT4, YP7CW4, YP7CX4, YY3KD4, YG9C64, YG9CR4, YG9CS4, YG9CV4, YG9CX4, YG9DA4, YG9DB4, YG9DC4 and YH7BE4.
- 510(k) numbers
- not on file
- PMA numbers
- ["P830055S074"]
- Product code
- NJL
- 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