NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
FDA device recall Z-1265-2024 · posted 2024-03-06 · Open, Classified
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- Reason for recall
- Potential packaging breaches of inner blister and outer sterile blister.
- Action taken
- URGENT MEDICAL DEVICE RECALL notifications dated 02/06/2024 were distributed to consignees by mail. Consignees were asked to forward the provided recall notice to all individuals within the organization who need to be made aware and organizations who have consigned product, immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of recalled devices, complete and return the provided Business Reply Form by email to strykerortho4004@sedgwick.com or by fax to 855-800-1093. Consignees are to contact their local sales office or Stryker Sales Representative for product replacement and inventory questions. Recalled devices are to be returned to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team, 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430; include "Ref PFA 3524019" on shipment. Consignees with any questions are to call the firm at 201-831-5000 or by email at SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. An URGENT MEDICAL DEVICE RECALL UPDATE, dated 3/18/24, was sent to consignees.
- Root cause
- Packaging
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 24 units (US); 1 unit (OUS)
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- Date initiated
- 2024-02-06
- Date posted
- 2024-03-06
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (K172634) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017-11-16 |