—#75731

Product

PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K081016
Affected lot / code info: Lot numbers: A1, A1B1107, A2, A3B1107, A3, A3B1107, A4, A4/I, A51767, A51767B706, B57815, B58460, B60400, and B62141

Why it was recalled

The product was breaking during use.

Root cause (FDA determination)

Other

Action the firm took

All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.

Recalling firm

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

Distribution

Distribution pattern: Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress

Timeline

Recall initiated: 2008-11-21
Posted by FDA: 2009-02-03
Terminated: 2012-11-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75731. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.