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FDA (Device enforcement)Recalled 2023-04-13class ii

Howmedica Osteonics Corp.: TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

Hazard

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Details from the source

Reason for recall: Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa Distribution: US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan Quantity: 24 units in total Lot/code info: GTIN: 07613327338560 Lot Number: 7H8RPL

UPC codes

07613327338560

Source

Official record: FDA (Device enforcement)

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

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