Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactu
FDA device recall Z-1297-2008 · posted 2008-03-25 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Screws do not have locking threads
- Action taken
- Recall notification letters (Urgent Product Recall) were sent on January 28, 2008 to all Stryker Branches/Agencies by Federal Express. All product distributed was requested to be located and returned, including from hospitals.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 100 units
- Distribution
- Nationwide-USA including states of MA, PA, GA, OH, and TX (hospital consignees) and Stryker Branches/Agencies in MA, NJ, PA, MD, VA, NC, GA, TN, KY, OH, MI, LK, OK, TX, and CA.
- Date initiated
- 2008-01-28
- Date posted
- 2008-03-25
- Date terminated
- 2008-06-04
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.