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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

Synthes USA HQ, Inc.: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Agency Publication Date: March 1, 2013
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Affected Products

Product: Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.

Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.

Lot Numbers:
numbers
Product: Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.

Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.

Lot Numbers:
numbers
Product: Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 64195
Status: Resolved
Manufacturer: Synthes USA HQ, Inc.
Manufactured In: United States
Units Affected: 3 products (2; 24; 18)

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.