FDA-Device2020-04-29Class II
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
Smith & Nephew, Inc.
Hazard
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
Sold states
Nationwide Foreign: AE AL AR AT AU BE BM BR CA CH CL CN CO CR CZ DE DK EC EE ES FI FR GB IE IL IN IT KR LT LV MT MX NO PA PE PL PR PT QA RU SE SG TH TR XK ZA
Affected count
125,196 (total)
Manufactured in
130 & 120 Forbes Blvd, N/A, Mansfield, MA, United States
Products
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1756-2020Don't want to check this manually?
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