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[Recalled] TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603 — Product packaging improper or incomplete seal of the pouch surrounding the ster… | FDA 2020-09-09

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductTWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Brand / manufacturerSmith & Nephew, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0156-2021
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date09 September 2020
EAN / barcode72202603

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Smith & Nephew, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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