Encore Medical Recalls Cobalt MV Bone Cement Due to Packaging Seal Loss
Encore Medical is recalling 840 units of Cobalt MV 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a loss of sterile packaging for a medical device used in surgery, which presents a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Encore Medical, Lp is recalling 840 units of Cobalt MV Bone Cement 40GM (REF 402438). The recall is due to a loss of the seal on the sterile Tyvek packaging used with the product. The affected lot numbers are 507830, 871270, and 959670.
The product was distributed nationwide. Cobalt MV 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. The loss of the sterile seal may compromise the sterility of the bone cement, which is a critical requirement for its intended surgical use.
Healthcare providers and patients should stop using the affected units and contact Encore Medical, Lp for further instructions or a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Encore Medical, Lp
- Category
- Medical Device — Bone Cement
- Affected units
- 840
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 (3)
- Lot Numbers: 507830
- 871270
- 959670
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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