Cobalt HV with Gentamicin — Class II medical device recall Z-0067-2018
Ongoing recall by Encore Medical, Lp, reported 2017-11-15, distributed nationwide. Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
| Recall number | Z-0067-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2017-06-26 |
| Classified | 2017-11-06 |
| Reported by FDA | 2017-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 9,848 units |
| Reason classes | sterility, packaging |
| Lot numbers | 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700 |
| Model numbers | 402283 |
Product
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, 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 for recall
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0067-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.