Z-0412-2018 Class II Terminated
FDA device recall Z-0412-2018 was initiated by MicroAire Surgical Instruments, LLC on May 22, 2017 and is designated Class II. Reason for recall: One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) The recall status is terminated (terminated August 29, 2018). Affected quantity: 42.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- May 22, 2017
- Termination Date
- August 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42
Product Description
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
Reason for Recall
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Distribution Pattern
US Distribution.
Code Information
LIT 0317305390