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FDA (Device enforcement)Recalled 2023-06-12class ii

Tornier, Inc: AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

Hazard

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Details from the source

Reason for recall: A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. Quantity: 55 units Lot/code info: GTIN 00846832069408, Serial Numbers: AZ1322077001, AZ1322077002, AZ1322077003, AZ1322077004, AZ1322077005, AZ1322077006, AZ1322077007, AZ1322077008, AZ1322077009, AZ1322077010, AZ1322077011, AZ1322077012, AZ1322077013, AZ1322077014, AZ1322077015, AZ1322077016, AZ1322077017, AZ1322077018, AZ1322077019, AZ1322077020, AZ1322077021, AZ1322077022, AZ1322077023, AZ1322077024, AZ1322077025, AZ1322077026, AZ1322077027, AZ1322077028, AZ1322077029, AZ1322077030, AZ1322077031, AZ1322077032, AZ1322077033, AZ1322077034, AZ1322077035, AZ1322077036, AZ1322077037, AZ1322077038, AZ1322077039, AZ1322077040, AZ1322077041, AZ1322077042, AZ1322077043, AZ1322077044, AZ1322077045, AZ1322077046, AZ1322077047, AZ1322077048, AZ1322077049, AZ1322077050, AZ1322077051, AZ1322077052, AZ1322077053, AZ1322077054, AZ1322077055

UPC codes

00846832069408

Source

Official record: FDA (Device enforcement)

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

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