Z-2734-2011

Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing...

Name: Z-2734-2011 Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing...
Creator: Encore Medical, Lp
Published: 2011-04-21
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2011-04-21 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the... on 2011-04-21. The reason FDA records is "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-2734-2011
Status: Terminated
Initiated: 2011-04-21
Posted: 2011-07-05
Terminated: 2012-04-06
Recalling firm: Encore Medical, LP
Product: Foundation Knee System Instrumentation, Tibial Broach Assembly. 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.
Product code: HTQ Broach
Reason for recall: Strike plate may dislodge from the broach stem handle during impaction of the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Encore Medical, Lp (d.b.a. DJO Global) sent out a "Urgent Field Safety Notice" dated April 20, 2011 to all affected customers. The firm also e-mailed the consignees as well. The letter described the product, affected lots, reason for recall and provided recommendations including; asking customers contact firm for a replacement, provided a "Field Safety Response Form" to fill out and return. The firm also e-mailed the consignees as well. For additional information please contact the Director of Commercial Logistics at (512) 834-6330 or the International Customer Service at 512 834-6275.
Quantity in commerce: 15 units
Distribution: Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan.
Product codes and lots: P/N 801-01-013 Lot 37641L01

Product code HTQ

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)