Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Steri
FDA device recall Z-0249-2016 · posted 2015-11-09 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.
- Action taken
- Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826. For questions regarding this recall call 201-831-5272.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 3,444 units
- Distribution
- Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.
- Date initiated
- 2015-09-29
- Date posted
- 2015-11-09
- Date terminated
- 2016-09-23
- 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 TRITANIUM TIBIAL BASEPLATE (K123486) | Stryker | 2013-05-03 |