Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. C
FDA device recall Z-1880-2025 · posted 2025-05-29 · Open, Classified
Recall details
- Recalling firm
- Onkos Surgical, Inc.
- Reason for recall
- Potential for breach of Tyvek seals.
- Action taken
- Onkos Surgical began notifying consignees on about 09/01/2023 via email. Consignees were instructed to complete and return the response form providing the affected lot numbers being returned, coordinate the return of affected units, and to note that when placing these parts into totes, always place them flat.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 49 units
- Distribution
- Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.
- Date initiated
- 2023-09-01
- Date posted
- 2025-05-29
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.