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FDA (Device enforcement)Recalled 2023-06-28class ii

Stryker Corporation: stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

Hazard

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

Details from the source

Reason for recall: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa). Distribution: Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand. Quantity: 1489 units Lot/code info: GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017

UPC codes

07613154028177

Source

Official record: FDA (Device enforcement)

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

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