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STANDARD RC NEEDLE

Biomet Orthopedics, LLC · Model 902969 · UDI-DI 00880304404816

GAB Prescription
8
510(k) clearances
560
Adverse events
7
Recalls
123
Facilities

Recalls

DateFirmReason
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl
2011-03-10Biomet, Inc.The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.