[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
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 / manufacturer | Surgical Instrument Service And Savings, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1631-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 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 →
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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.