Device product
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
Z-0412-2018
Product summary
- Event
- Event 78687
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0412-2018
Official wording
Reason: One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Code information: LIT 0317305390
Distribution pattern: US Distribution.
Derived failure modes
-
Unknown
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)