FDA Device

Depuy LCS Complete RP insert; polyethylene tibial insert SM+, 10 mm; Ref 1294-05-210.

Hazard

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

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Products

Depuy LCS Complete RP insert; polyethylene tibial insert SM+, 10 mm; Ref 1294-05-210.
Brand
Depuy Orthopaedics, Inc.
UPC
Lots X3BCV4, X3BCY4, Y5FA24, Y5FA34 and Y5FA54.

Units Affected

51

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