Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixat
FDA device recall Z-2791-2016 · posted 2016-09-13 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
- Action taken
- The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 30, 2016 by e-mail to its customer requesting that they quarantine affected devices and sent the letter via UPS (with return receipt) on July 1, 2016. The letter described the product, problem and actions to be taken. The customer was instructed to inform users of the Medical Device Removal and forward the notice to all who need to be aware; inspect your inventory and return affected products to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team; 325 Corporate Drive; Dock M-East , Mahwah, NJ 07431 REF: PFA #2016-094; complete and return the Business Reply Form via email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days; and keep a copy of the completed and executed Business Reply Form for your records. If you have any questions, feel free to contact the Mgr., Divisional Regulatory Compliance, Marketing Quality at (201) 831-6693.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 1 unit in total
- Distribution
- US distribution to state of: CA.
- Date initiated
- 2016-06-30
- Date posted
- 2016-09-13
- Date terminated
- 2017-06-21
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T2 SUPRACONDYLAR NAIL SYSTEM (K023267) | Howmedica Osteonics Corp. | 2002-12-11 |