Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File
FDA device recall Z-0964-2013 · posted 2013-03-18 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
- Action taken
- A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 4 units (total of 2 sets)
- Distribution
- 1 Branch (NJ) with one consignee (DE).
- Date initiated
- 2013-01-24
- Date posted
- 2013-03-18
- Date terminated
- 2015-05-06
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIATHLON TOTAL KNEE SYSTEM (K053514) | Stryker Orthopaedics | 2006-01-26 |