FDA Device

Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.

Hazard

An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.

What You Should Do

Remedy

Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.

Products

Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
Brand
Zimmer Inc.
UPC
Lot 60954069.

Units Affected

5