Recall Z-2038-2020— Pega Medical Inc.
Class III · Terminated
Class III FDA medical device recall by Pega Medical Inc., initiated 2020-04-03, terminated 2020-11-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label..
- Recalling firm
- Pega Medical Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-04-03
- Terminated
- 2020-11-20
- Firm location
- Laval, N/A, Canada
Product description
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.
Reason for recall
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.