Z-0067-2018 Class II Ongoing
FDA device recall Z-0067-2018 was initiated by Encore Medical, Lp on Jun 26, 2017 and is designated Class II. Reason for recall: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. The recall status is ongoing. Affected quantity: 9848 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 15, 2017
- Initiation Date
- Jun 26, 2017
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0067-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026