Z-0010-2008

EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis...

Name: Z-0010-2008 EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis...
Creator: Encore Medical, Lp
Published: 2007-08-09
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2007-08-09 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin... on 2007-08-09. The reason FDA records is "Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0010-2008
Status: Terminated
Initiated: 2007-08-09
Posted: 2007-10-10
Terminated: 2008-03-10
Recalling firm: Encore Medical, LP
Product: EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Product code: HWA Impactor
Reason for recall: Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
Root cause tag: design
FDA root cause: Device Design
Action: Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.
Quantity in commerce: 5 units.
Distribution: Products distributed to direct accounts in CA, FL and MD.
Product codes and lots: All lots.

Product code HWA

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)