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Recall Observatory FDA recall evidence

Device product

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Z-0581-2025

October 29, 2024

Class II

Product summary

Firm
Smith & Nephew Inc.
Event
Event 95654
Status
Ongoing
Classification
Class II
Quantity
2,156 units
Official record key
device-enforcement:Z-0581-2025

Official wording

Reason: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Code information: Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

Distribution pattern: Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    inadequate packaging
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterile barrier breach