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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

MEDLINE INDUSTRIES, LP - Northfield: The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.

Agency Publication Date: February 1, 2023
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Affected Products

Product: MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008

GTIN 10193489120387, Lot Number 810304

Lot Numbers:
Number
Product: MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008

GTIN 10193489120707, Lot Number 810304

Lot Numbers:
Number
Product: MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

GTIN 10888277699113, Lot Number ?

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91491
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 3 products (420 units; 420 units; 190 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.