[Recalled] Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories — Insufficient seal strength on sterile barrier packaging | FDA 2016-04-01
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories |
|---|---|
| Brand / manufacturer | Biomet, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1816-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 April 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
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 Biomet, 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.