Recall Z-0803-2015 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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.
| Date | Dec 16, 2014 (initiated Oct 6, 2014) |
| Status | Terminated |
| Reason | Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 15 units |
| Distribution | Distributed to GA, IN, MI, NJ, OH, PA, TX & VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.