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FDA (Device enforcement)Recalled 2025-11-24class ii

Zimmer Surgical Inc: Zimmer Dermatome AN, Model/Catalog Number: 88710100

Hazard

The devices may have a misaligned thickness control bar.

Details from the source

Reason for recall: The devices may have a misaligned thickness control bar. Distribution: Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the distribution and the identification of the domestic consignees. Quantity: 498 units Lot/code info: Lot Code: Model No 88710100, UDI 00889024464834701341, Lot Number 65900465, Serial Number 701341; Model No 88710100, UDI 00889024464834701343, Lot Number 65900465, Serial Number 701343; Model No 88710100, UDI 00889024464834701344, Lot Number 65900465, Serial Number 701344; Model No 88710100, UDI 00889024464834701345, Lot Number 65900465, Serial Number 701345; Model No 88710100, UDI 00889024464834701346, Lot Number 65900465, Serial Number 701346; Model No 88710100, UDI 00889024464834701350, Lot Number 65900465, Serial Number 701350; Model No 88710100, UDI 00889024464834701351, Lot Number 65900465, Serial Number 701351; Model No 88710100, UDI 00889024464834701352, Lot Number 65900465, Serial Number 701352; Model No 88710100, UDI 00889024464834701353, Lot Number 65900465, Serial Number 701353; Model No 88710100, UDI 00889024464834701354, Lot Number 65900465, Serial Number 701354; Model No 88710100, UDI 00889024464834701355, Lot Number 65900465, Serial Number 701355; Model No 88710100, UDI 00889024464834701356, Lot Number 65900465, Serial Number 701356; Model No 88710100, UDI 00889024464834701357, Lot Number 65900465, Serial Number 701357; Model No 88710100, UDI 00889024464834701359, Lot Number 65900465, Serial Number 701359; Model No 88710100, UDI 00889024464834701361, Lot Number 65944825, Serial Number 701361; Model No 88710100, UDI 00889024464834701362, Lot Number 65944825, Serial Number 701362; Model No 88710100, UDI 00889024464834701363, Lot Number 65944825, Serial Number 70

Source

Official record: FDA (Device enforcement)

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

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