Z-0170-04

TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635

Name: Z-0170-04 TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635
Creator: Plus Orthopedics
Published: 2002-09-09
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2002-09-09 / Terminated / root cause: manufacturing process

FDA source

Plus Orthopedics began a recall of TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635 on 2002-09-09. The reason FDA records is "Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0170-04
Status: Terminated
Initiated: 2002-09-09
Posted: 2003-11-27
Terminated: 2003-12-30
Recalling firm: Plus Orthopedics
Product: TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
Quantity in commerce: 5
Distribution: TX,
Product codes and lots: Lot 0006.13.2635

Product code JWH

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)