Recall Z-0065-2018 ยท LOD Bone Cement
Encore Medical, Lp
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 reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, n
| Date | Nov 6, 2017 (initiated Jun 26, 2017) |
| Status | Open, Classified |
| Reason | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. |
| 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 DJO5504@stericycle.com or by |
| Quantity | 840 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091608 | COBALT MV BONE CEMENT Biomet Manufacturing Corp, Sep 17, 2009 |