Z-0067-2018 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- June 26, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9848 units
Product Description
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
Reason for Recall
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Distribution Pattern
Nationwide Distribution
Code Information
Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700