Device product
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Z-0563-2020
Product summary
- Event
- Event 84180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-0563-2020
Official wording
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products.
Code information: Lot Number 1568030
Distribution pattern: US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Derived failure modes
-
Unknown
The firm discovered a lack of adequate documentation confirming sterility on certain products.