META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Recall #Z-1806-2025 — Class II — March 18, 2025
Product Description
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Reason for Recall
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.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
75
Distribution
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.
Code Information
UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated