Z-0107-04

17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant...

Name: Z-0107-04 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant...
Creator: Plus Orthopedics
Published: 2003-08-01
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2003-08-01 / Terminated

FDA source

Plus Orthopedics began a recall of 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 on 2003-08-01. The reason FDA records is "Plastic insert over articular surface of knee joint replacement may become dislodged". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0107-04
Status: Terminated
Initiated: 2003-08-01
Posted: 2003-11-13
Terminated: 2004-12-12
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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: Plastic insert over articular surface of knee joint replacement may become dislodged.
FDA 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 in commerce: 35
Distribution: AZ, ID, TX CTdistributors.
Product codes and lots: No code information applies.

Product code KRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)