RegWardenFDA facility compliance records
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
ReasonA packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
ProductSUTUREFIX ULTRA Suture, Product number 72203855
Quantity868
DistributionDomestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore South Africa Spain Sweden Switzerland
Initiated2020-06-24
Classified2020-07-31
Recall numberZ-2746-2020
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-2746-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85981/

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