Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI
FDA device recall Z-0065-2015 · posted 2014-10-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.
- Action taken
- Stryker Orthopaedics sent an "Urgent Medical Device Removal" letter dated July 23, 2014 and Business Reply Form to their Branches/Agencies via e-mail on July 23, 2014 and their Hospital Risk Management was sent Notification Letters and Product Accountability Forms via FedEx (with return receipt) by July 24, 2014. The recall letter informed the customer of the problem. The customer was asked to return all affected products available to Stryker Osteosynthesis, c/o Paul Jahnke, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, REF: PFA #2014-101 or Contact Stryker's customer service and refer to PFA #2014-101 for returning the product to Stryker. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to: 1 (855) 251-3635 or email a copy to Aminah Crawford, Recall Coordinator at aminah.crawford@stryker.com.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 484 units
- Distribution
- US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
- Date initiated
- 2014-07-24
- Date posted
- 2014-10-14
- Date terminated
- 2017-06-08
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T2 TIBIAL NAILING SYSTEM (K131365) | Stryker Trauma AG | 2013-10-10 |