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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

Biomet, Inc.: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Agency Publication Date: June 16, 2014
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Affected Products

Product: EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

Part numbers 110007380 Lot 223570 and 803860

Lot Numbers:
223570
Product: EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

Part numbers 110007379 Lot 060830 and 258920,

Lot Numbers:
060830
Product: EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

Part # 904050 Lots M224900, M175380, M060840,Part ##904051 Lots M224930, M224970, M175390 and M060850,Part # 904052 Lots M298610, M225000, M225010, and M060860; Part #904053 Lots M225030, M225020 and M048380; Part # 904054 Lots M225040, M225050, M175420, M060870; Part # 904055 Lot M060880; and Part # 904056 Lots M225100, M175440, and M060890.

Lot Numbers:
M060880

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68216
Status: Resolved
Manufacturer: Biomet, Inc.
Manufactured In: United States
Units Affected: 3 products (100 units; 100 units; 102)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.