—#87911

Product

Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013106
Affected lot / code info: Catalog number: 6276-5-014; Lot number: 20568201, Exp 11/23/2011.

Why it was recalled

The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.

Root cause (FDA determination)

Process control

Action the firm took

Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.

Recalling firm

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

Distribution

Distribution pattern: 1 device distributed to a hospital in GA.

Timeline

Recall initiated: 2009-12-30
Posted by FDA: 2010-03-11
Terminated: 2012-09-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.