Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122,
FDA device recall Z-0869-2009 · posted 2009-01-12 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.
- Action taken
- Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HRY
- Quantity affected
- 8 mm - 1 unit; 12 mm - 8 units.
- Distribution
- Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
- Date initiated
- 2008-11-25
- Date posted
- 2009-01-12
- Date terminated
- 2010-08-30
- 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 PKR SYSTEM (K071881) | Howmedica Osteonics Corp. | 2007-10-09 |