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Recall Observatory FDA recall evidence

Device product

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2385-2020

May 07, 2020

Class II

Product summary

Firm
Stryker GmbH
Event
Event 85681
Status
Terminated
Classification
Class II
Quantity
US:127; OUS 454
Official record key
device-enforcement:Z-2385-2020

Official wording

Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information: Lot Number: K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility cannot be assured