Device product
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Z-1487-2017
Product summary
- Event
- Event 76687
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1487-2017
Official wording
Reason: Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
Code information: Lot Number 101868
Distribution pattern: Al, FL, IN, Il, NE, TX, NM, CO, AZ
Derived failure modes
-
Unknown
Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.