FDA Device recall Z-0064-2018
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…
- FDA Device
- Class II
- ongoing
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of 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… by Encore Medical, citing loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0064-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-06-26 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | US |
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 necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
Reason
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Identifiers
| code_info | Lot Numbers: 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, 959720 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0064-2018%22
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