Z-1838-2017 Class II Terminated
FDA device recall Z-1838-2017 was initiated by Smith & Nephew, Inc. on March 15, 2017 and is designated Class II. Reason for recall: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming The recall status is terminated (terminated July 10, 2018). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 15, 2017
- Termination Date
- July 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Reason for Recall
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Distribution Pattern
Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
Code Information
Batch Numbers: G11243 G11244 G18810 G18813 G32171 G32172