CLASS II ONGOING Device recall · Reported 15 Nov 2017 · FDA Enforcement Report

Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM recalled

Encore Medical is recalling Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, distributed nationwide in the US. The recall was initiated on 26 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 508250, 959680

Quantity recalled1815 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0066-2018
FDA event ID: 77801
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jun 2017
FDA classified: 6 Nov 2017
Reported: 15 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

26 Jun 2017	Recall initiated by company
6 Nov 2017	Classified by FDA	+133 days
15 Nov 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM recalled?

Yes. Encore Medical recalled Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM on 26 Jun 2017. The recall is Class II and its status is Ongoing. Recall number Z-0066-2018.

Why was it recalled?

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

Which lots are affected?

Lot Numbers: 508250, 959680

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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