Reported May 27, 2020 · Terminated
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM…
Pega Medical Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pega Medical Inc. · 1111 Chomedey (A-13) E · Laval, N/A · N/A
Is this the product you have?
- Orthopedic manual Surgical Instrument handle for Simple Locking Intra
- Medullary (SLIM) System - Product UsageThe SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures
- Lot codes and dates
- SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
- Amount recalled
- 3 units
Where it was sold
- Nationwide
- FL
Why it was recalled
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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