[Recalled] Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plas
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is n |
|---|---|
| Brand / manufacturer | Encore Medical, Lp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0064-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 26 June 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
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 Encore Medical, Lp
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.