Z-0064-2018Class II

Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV...

Name: Z-0064-2018 Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV...
Creator: Encore Medical, Lp
Published: 2017-06-26
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-06-26 / Open, Classified / root cause: supplier

FDA source

Encore Medical, Lp began a recall of 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... on 2017-06-26. FDA classified it as Class II and gives the reason as "Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0064-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-06-26
Posted: 2017-11-06
Recalling firm: Encore Medical, LP
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 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
Product code: LOD Bone Cement
Reason for recall: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 2017 to all affected customers. The firm initiated their recall to their distributors on 06/26/2017 requesting that they destroy any product on hand. The firm then expanded their recall on 09/14/2017, beginning their notification by email and following with letters to hospitals delivered on 09/21 and 09/22/2017. The firm requested the following actions: "1. Complete the Acknowledgement/Questionnaire provided with this lot specific field safety notice and return to Stericycle by email to [email protected] or by fax to 866-608-3939. If you have any questions or issues related to sending this information, please call 877-551-7153. 2. Quarantine this affected product. Arrangements will be made to finalize the handling of the product as well as coordinate the replacement product where applicable. 3. If packaging issues are found, please contact DJO Surgical Customer Service to initiate a product complaint." Customers with questions were instructed to call 512-834-6255.
Quantity in commerce: 7143 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, 959720

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0064-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0064-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-15	2017-11-06
Z-0065-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-15	2017-11-06
Z-0066-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-15	2017-11-06
Z-0067-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-15	2017-11-06

Product code LOD

K051496Class IICobalt Bone CementBiomet, Inc. / cleared 2005-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)