Z-0349-2012

Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial...

Name: Z-0349-2012 Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial...
Creator: Encore Medical, Lp
Published: 2011-10-26
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2011-10-26 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare... on 2011-10-26. The reason FDA records is "The strike plate may dislodge from the broach stem handle during impaction of the device". 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-0349-2012
Status: Terminated
Initiated: 2011-10-26
Posted: 2011-12-02
Terminated: 2012-09-05
Recalling firm: Encore Medical, LP
Product: Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The strike plate may dislodge from the broach stem handle during impaction of the device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255.
Quantity in commerce: 30 units
Distribution: Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy
Product codes and lots: Lot#'s 35149L02, 36204L06, 37990L06, 38272L13, and 50479L12

Product code JWH

K970031Class IIFoundation Knee System Tibial ComponentEncore Orthopedics, Inc. / cleared 1997-04-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)