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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Zimmer, Inc.: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Agency Publication Date: August 14, 2014
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Affected Products

Product: Double Offset Rasp Handle, Left Hand Nonsterile

Item Number 82016757821 Lot Number 97005188, 97005789

Lot Numbers:
Number
Product: Double Offset Rasp Handle, Left Hand Nonsterile

Item Number 82016757830 Lot Number 97009559

Lot Numbers:
Number
Product: Double Offset Rasp Handle, Left Hand Nonsterile

Item Number 82016757831 Lot Number 97008287, 97900066, 97900084, 97900106, 97900158

Lot Numbers:
Number
Product: VI DBL OFFST W/ LRG STPL, LT Nonsterile

Item Number 82016757841 Lot Number 97009219, 97009254

Lot Numbers:
Number
Product: Double Offset Rasp Handle, Right Hand Nonsterile

Item Number 82016757922 Lot Number 97005189, 97005833

Lot Numbers:
Number
Product: Double Offset Rasp Handle, Left Hand Nonsterile

Item Number 82016757931 Lot Number 97009560

Lot Numbers:
Number
Product: Double Offset Rasp Handle, Right Hand Nonsterile

Item Number 82016757932 Lot Number 97008288, 97900067, 97900085, 97900107, 97900157

Lot Numbers:
Number
Product: Vl DBL OFFST WI LRG STPL, RT Nonsterile

Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585

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Number
Product: VER2 DBL OFFSET RASP HANDLE, LT Nonsterile

Item Number 82016761201 Lot Number 97009494, 97009561, 97009569

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Number
Product: VER2 D8L OFFSET RASP HANDLE, RT Nonsterile

Item Number 82016761302 Lot Number 97009564, 97009565, 97009570

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Number
Product: Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)

Item Number 00780803521 Lot Number 56474891, 56474892, 56474893, 56474894

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Number
Product: Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896

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Number
Product: VER2 HANDLE, PIN REWORK, LT Nonsterile

Item Number 82-0167-612-31, Lot Number 97009753, 97010150

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Number
Product: VER2 HANDLE, PIN REWORK, RT Nonsterile

Item Number 82-0167-613-32 Lot Number 97010151

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Number
Product: 23.5 Deg Rasp Handle Assy- LEFT Nonsterile

Item Number 82-0167-636-00 Lot Number 97009530, 97009782

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Number
Product: 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile

Item Number 82-0167-636-20 Lot Number 97009531, 97009781

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68656
Status: Resolved
Manufacturer: Zimmer, Inc.
Manufactured In: United States
Units Affected: 15 products (412 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.