[Recalled] Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty — As a result of the insufficient sealer calibration data for
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 | Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty |
|---|---|
| Brand / manufacturer | Zimmer Manufacturing B.V. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1160-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 January 2016 |
| EAN / barcode | 62313588 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
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 Zimmer Manufacturing B.V.
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.