Recall Z-0803-2015
Stryker Spine · initiated October 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
Codes / lots: Lot number 4279
Reason for recall
Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.
FDA-determined cause: Nonconforming Material/Component
Action taken
Stryker Spine sent an Urgent Medical Device Removal Notification/Acknowledgement Form dated 10/6/2014 via Fed Ex. The letter identified the affected product, discussed the product description, product issue, potential hazards, risk mitigations, and actions needed. Customers were asked to read the notice thoroughly and make sure that it is understood. Additionally, they are to complete the enclosed acknowledgement form and fax or e-mail it back.
Details
- Recall number
- Z-0803-2015
- Initiated
- October 6, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- May 8, 2017
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 15 units
- Distribution
- Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
- Recalling firm
- Stryker Spine, Allendale, NJ