Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0066-2018·Announced 2017-11-15

Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

Encore Medical, Lp is recalling 1,815 units of Cobalt MV with Gentamicin bone cement because the sterile Tyvek packaging seal was lost.

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 involves 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 1,815 units of Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM (REF 402439). The recall is due to a loss of the seal on the sterile Tyvek packaging used with the product. The affected lot numbers are 508250 and 959680.

The product 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 recall is classified as Class II by the FDA. The affected units were distributed nationwide.

Consumers and healthcare providers should stop using the affected bone cement and contact Encore Medical, Lp for further instructions or a return.

The recalled product

Product: 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…
Manufacturer: Encore Medical, Lp
Category: Medical Device — Orthopedic Bone Cement
Hazard: packaging-defect
sterility-compromise
Affected units: 1,815

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 (2)

Lot Numbers: 508250
959680

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.

See all 4 products in this recall →

Same manufacturer · Encore Medical, Lp

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