—#83474

Product

Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.

FDA product code: JDW — Pin, Fixation, Threaded
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K994143
Affected lot / code info: All Lots

Why it was recalled

Hinge failure: The product is cracking or breaking during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.

Timeline

Recall initiated: 2009-01-23
Posted by FDA: 2009-09-15
Terminated: 2013-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83474. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.