T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteoni
FDA device recall Z-0481-2011 · posted 2010-11-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.
- Action taken
- Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product. Stryker can be contacted about this issue at 201 831-5118.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 8 sets
- Distribution
- Nationwide Distribution: To one location in New Jersey.
- Date initiated
- 2006-08-02
- Date posted
- 2010-11-26
- Date terminated
- 2013-11-22
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.