Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 1
FDA device recall Z-0803-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 15 units
- Distribution
- Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
- Date initiated
- 2014-10-06
- Date posted
- 2014-12-16
- Date terminated
- 2017-05-08
- Location
- Allendale, NJ
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