Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57
FDA device recall Z-0381-2013 · posted 2012-11-19 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
- Action taken
- Stryker Spine sent an Urgent Medical Device Removal Notification letter/Product Accountability Forms dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 201-760-8150.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 19 units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
- Date initiated
- 2012-08-09
- Date posted
- 2012-11-19
- Date terminated
- 2015-09-30
- Location
- Allendale, NJ
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