Stryker Howmedica Osteonics Corp.

Recalling Firm / Manufacturer

Stryker Howmedica Osteonics Corp.

Product

Code Information

Source

SCORPIO NRG KNEE SYSTEM

Catalog number 81-4407L, lot code MHHEY8 and Catalog number 81-4407R, lot codes: MHHAEV and MHHM4K.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog number 80-4405L, Lot codes: MHJ1HW and MHJ4RV and Catalog number 80-4405R, Lot codes: MHE4E0 and MHJ4RW.

U.S.FDA

OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM

Catalog number 70-3007R, Lot code MHHR5W.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog Number 81-4403L, Lot number MHEJ9R.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog Number 81-4409L, Lot code MHHK14.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog number 81-4404L, lot code MHHDR0 and Catalog number 81-4404R, lot code MHHN7J.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog number 81-4405L, lot code MHHKXX.

U.S.FDA

OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM

Catalog number 71-3003L, lot code MHHK2X and Catalog number 71-3005R, lot code MHH378.

U.S.FDA

OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM

Catalog number 71-4505L, lot code MHHT6L and Catalog number 71-4505R, lot codes: L MHHL20 and MHHR6W.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog number 80-4408L, lot code MHH8J4.

U.S.FDA

SCORPIO NRG KNEE SYSTEM

Catalog number 80-4407R, Lot code MHJ09J.

U.S.FDA

OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM

Catalog number 70-4107R, Lot code MHHDME.

U.S.FDA

Description

Scorpio NRG Posterior Stabilized Femoral, left/right; Stryker Orthopaedics,325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert.

Reason of Recall

It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

Date Recall Initiated

October 2, 2009

Action

An "Urgent Product Recall" letter was sent on October 2, 2009 by Federal Express to Stryker branches and Hospital Risk Management Departments in the United States as well as foreign consignees. The letter described the issue, potential hazard and actions for affected accounts. Consignees were instructed to examine their inventory and return recalled product as instructed in the notification letter to Stryker Orthopaedics. In addition, consignees were instructed to reconcile affected product by completing the attached Product Accountability form.

Contact

Al-Faisaliah Medical System
Riyadh
(01) 2119988

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.