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Recall Observatory FDA recall evidence

Device product

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Z-1806-2025

March 18, 2025

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 96586
Status
Ongoing
Classification
Class II
Quantity
75
Official record key
device-enforcement:Z-1806-2025

Official wording

Reason: Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

Code information: UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034

Distribution pattern: Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.