FDA Device

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

Hazard

The product was breaking during use.

What You Should Do

Remedy

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.

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Products

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
Brand
Smith & Nephew Inc
UPC
Lot numbers: A1, A1B1107, A2, A3B1107, A3, A3B1107, A4, A4/I, A51767, A51767B706, B57815, B58460, B60400, and B62141

Units Affected

159 units

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