Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee Syste
FDA device recall Z-2389-2015 · posted 2015-08-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
- Action taken
- Stryker Orthopaedics sent a recall notification via email on 5/29/2015 to their local branches. Notification letters and Product Accountability Forms were sent to Stryker branches/agencies with return receipts on 7/2/2015.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 10 units
- Distribution
- OH, SC, RI, WV
- Date initiated
- 2015-05-29
- Date posted
- 2015-08-14
- Date terminated
- 2016-09-26
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (K141056) | Stryker Orthopaedics | 2014-08-05 |