ZIMMER ORTHOPEDIC MFG LTD: NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

Is my product affected?

NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

• UPC 00889024001152

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Orthopedic Manufacturing Ltd. is recalling 7 NexGen LPS Femoral Component devices (Size G, for left and right knees) due to undersized protective foam inserts used in packaging. The undersized foam may cause a breach in the inner cavity during transportation, potentially compromising the product. The affected devices were distributed worldwide, including to California, Massachusetts, Maine, Michigan, Minnesota, and Wisconsin in the United States, as well as to Germany, France, and Italy.

The recalled devices have Item Number 00-5964-017-51 and four specific lot numbers (UDI Numbers): 63329529, 63342472, 63329533, and 63329527. According to the source document, no remedy information is provided for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.

Details from the source

Reason for recall: There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation. Distribution: Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy. Quantity: 7 devices Lot/code info: Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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