Device product
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Z-2038-2020
Product summary
- Event
- Event 85531
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2038-2020
Official wording
Reason: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Code information: SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
Distribution pattern: US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Derived failure modes
-
Unknown
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.