Agency classClass IIOur severity:High FDA (Devices)·Z-0067-2018·Announced 2017-11-15

Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

Encore Medical, Lp is recalling Cobalt HV with Gentamicin bone cement because the sterile Tyvek packaging may have lost its seal, 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 sterile medical device where loss of the packaging seal creates a risk of contamination and potential infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Encore Medical, Lp is recalling 9,848 units of Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM (REF 402283). The recall was initiated due to a loss of the seal on the sterile Tyvek packaging used for the product. This defect may compromise the sterile barrier, posing a risk of contamination to the bone cement.

The affected 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 covers specific lot numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, and 959700. The product was distributed nationwide.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the product if the packaging seal is compromised. Patients who have already received the product should contact their healthcare provider for guidance.

The recalled product

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…
Manufacturer: Encore Medical, Lp
Category: Medical Device — Orthopedic Implant
Hazard: contamination
infection
Affected units: 9,848

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 (11)

Lot Numbers: 189690
189760
199180
424740
508240
560290
595660
638280
786630
959650
959700

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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