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.
This recall has been terminated (originally issued November 13, 2003).
- Company
- Plus Orthopedics
- Recall Initiated
- August 1, 2003
- Posted
- November 13, 2003
- Terminated
- December 12, 2004
- Recall Number
- Z-0107-04
- Quantity
- 35
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Plastic insert over articular surface of knee joint replacement may become dislodged.
Distribution
AZ, ID, TX CTdistributors.
Lot / Code Info
No code information applies.
Root Cause
Other
Action Taken
Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.
More recalls by Plus Orthopedics
UltraCongruent Tibial Insert Model 0214703
Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
Feb 15, 2005
Biolox Ceramic Head XL
Jul 20, 2004