Encore Medical Cobalt Bone Cement Recall: Packaging Seal Loss Risk
Encore Medical recalls Cobalt HV with Gentamicin bone cement (REF 402283) due to potential packaging seal loss. This could compromise sterility during medical procedures. Affected patients should contact their doctor for guidance.
Lower-risk recall
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Contact the company
What happened, in plain English
Encore Medical is recalling a specific cobalt bone cement product because the sterile packaging may lose its seal. This could lead to contamination during surgery, making the product unsafe for use in medical procedures. Read more at govinfonow.com/recall/73563-encore-medical-cobalt-bone-cement-recall-packaging-seal-loss-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73563-encore-medical-cobalt-bone-cement-recall-packaging-seal-loss-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0067-2018
Cite this page
“Encore Medical Cobalt Bone Cement Recall: Packaging Seal Loss Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73563-encore-medical-cobalt-bone-cement-recall-packaging-seal-loss-risk. Based on FDA recall #Z-0067-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0067-2018%22&limit=1).
Why it’s dangerous
The sterile Tyvek packaging may lose its seal, potentially allowing contamination. This could lead to infection or other complications during surgery if the cement is not properly sterile.
Who’s affected
Patients prescribed this bone cement by a doctor for joint procedures. Those using the product without medical supervision are not affected.
How to tell if you have this one
Check for the product name 'Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM' with reference number 402283. The product was sold with specific lot numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700.
- Brand
Encore Medical- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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 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; Lot Numbers: 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, 959720 | 7143 units |
| Z-0065-2018 | Cobalt MV Bone Cement 40GM, REF 402438, 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; Lot Numbers: 507830, 871270, 959670 | 840 units |
| Z-0066-2018 | Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, 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; Lot Numbers: 508250, 959680 | 1815 units |
| Z-0067-2018 | 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; Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700 | 9848 units |
What to do — step by step
Check Product Details
Verify the product name, reference number, and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0067-2018 (June 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0067-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.