Biomet Cobalt HV Bone Cement Recalled for Packaging Seal Loss
Encore Medical is recalling Biomet Cobalt HV Bone Cement because the sterile Tyvek packaging seal may be lost, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging defect (loss of sterile seal) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Encore Medical, Lp is recalling Biomet Cobalt HV Bone Cement, a sterile, prescription-only medical device used in arthroplastic procedures to fix prosthetic parts to bone. The recall involves 7,143 units distributed nationwide.
The reason for the recall is the loss of the seal on the sterile Tyvek packaging used with the product. This defect may compromise the sterility of the bone cement.
The affected lot numbers are 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, and 959720. Healthcare providers and facilities should stop using the affected units and contact the recalling firm for instructions on return or disposal.
The recalled product
- 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…
- Manufacturer
- Encore Medical, Lp
- Affected units
- 7,143
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot Numbers: 508220
- 189680
- 199200
- 310390
- 424730
- 668130
- 668150
- 871240
- 959720
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Encore Medical, Lp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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