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Recall

Class II — Smith & Nephew, Inc.

Recalling firmSmith & Nephew, Inc.
Registered facilityView this company's 15 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonIntegrated 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.
ProductMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Quantity75
DistributionWorldwide - 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.
Initiated2025-03-18
Classified2025-05-19
Recall numberZ-1806-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Smith & Nephew, Inc. (Z-1806-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96586/

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