FDA Medical Device Recalls (openFDA)
Plus Orthopedics: 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
- Recall number
- Z-0107-04
- Recalling firm
- Plus Orthopedics
- Product
- 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
- Status
- Terminated
- Initiated
- 2003-08-01
- Posted
- 2003-11-13
- Terminated
- 2004-12-12
- Reason
- Plastic insert over articular surface of knee joint replacement may become dislodged.
- Root cause
- Other
- Action
- Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.
- Quantity
- 35
- Distribution
- AZ, ID, TX CTdistributors.
- Lot, serial or model codes
- No code information applies.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3001237832
- Firm city
- San Diego
- Firm state
- CA
- 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