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Recall Observatory FDA recall evidence

Device product

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2382-2020

May 07, 2020

Class II

Product summary

Firm
Stryker GmbH
Event
Event 85681
Status
Terminated
Classification
Class II
Quantity
OUS: 1404
Official record key
device-enforcement:Z-2382-2020

Official wording

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

Code information: Lot Number: K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03

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