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[Recalled] - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Product- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System
Brand / manufacturerSurgical Instrument Service And Savings, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1631-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date03 May 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of 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 Surgical Instrument Service And Savings, 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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