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[Recalled] Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. — 103 packaged and labeled tubes (103 product

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

ProductBrasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
Brand / manufacturerBrasseler USA I Lp
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0884-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date11 December 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.

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 Brasseler USA I Lp

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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