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PROFIX

Smith & Nephew, Inc. · Model 71508213 · UDI-DI 03596010221124

KWH Prescription
10
510(k) clearances
149
Adverse events
2
Recalls
33
Facilities

Description

PROFIX CONFORMING PLUS TIBIAL INSERT LEFT SIZE 1 14MM

Recalls

DateFirmReason
2009-04-06Tornier, Inc.Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the
2009-03-01Sgarlato Med, LLCProducts with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The o

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.