[Recalled] Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM — During the rework process for the April 17, 2017, field action, it was detected… | FDA 2017-08-07
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM |
|---|---|
| Brand / manufacturer | Zimmer Biomet, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0432-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 07 August 2017 |
| EAN / barcode | 814611280 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
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.