Recall Z-0621-2021— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2020-11-25, terminated 2024-05-08. It names one FDA 510(k) clearance: K991807. Product: Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.. Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-25
- Terminated
- 2024-05-08
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.
Reason for recall
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.