Reported Dec 9, 2015 · Terminated

Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total…

Stryker Howmedica Osteonics Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.

Lot codes and dates: Multiple Lot Numbers
Catalog Numbers
6630-6-105
6630-6-110
6630-6-125
6630-6-130
6630-6-150
6630-6-155
6630-6-170
6630-6-175
6630-6-205
6630-6-210
6630-6-225
6630-6-230
6630-6-250
6630-6-255
6630-6-270
6630-6-275
6630-6-305
6630-6-310
6630-6-325
6630-6-330
6630-6-350
6630-6-355
6630-6-370
6630-6-375
6630-6-405
6630-6-410
6630-6-425
6630-6-430
6630-6-450
6630-6-455
6630-6-470 and 6630-6-475
Amount recalled: 2,577 units

Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

47 in total.