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[Recalled] 4.5 mm Malleolar Screw Sterile zimmer — Zimmer is recalling various trauma screws that failed a leak test due to damage… | FDA 2014-07-22

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

Product4.5 mm Malleolar Screw Sterile zimmer
Brand / manufacturerZimmer, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2250-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date22 July 2014

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

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 Zimmer, 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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