Device 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 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
Z-0067-2018
Product summary
- Event
- Event 77801
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9848 units
- Official record key
device-enforcement:Z-0067-2018
Official wording
Reason: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Code information: Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.