—#79231

Product

Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040749
Affected lot / code info: All lots

Why it was recalled

Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Urgent Product Recall letters, dated 1/30/2009, were sent to all Branches/agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons on January 30, 2009 via Federal Express. The letter asked consignees to examine their inventory and determine if they had any affected products, remove and quarantine affected product from their inventory, and complete the attached Product Recall Acknowledgment Form. The letter also stated that a Stryker Orthopaedics Sales representative would contact the consignee to reconcile and return the product . Consignees should contact their Stryker sales rep if they weren't not contacted by them. Questions should be directed to Colleen O'Meara at 201-831-5970.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-01-30
Posted by FDA: 2009-04-17
Terminated: 2010-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.