[Recalled] OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor — Pinholes detected in a small number of primary pouches that may constitute a br… | FDA 2013-08-06
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor |
|---|---|
| Brand / manufacturer | Smith & Nephew, Inc. Endoscopy Division |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2225-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 06 August 2013 |
| EAN / barcode | 50272330 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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. Endoscopy Division
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.