FDAFDA · Food and drugs·Recall number Z-2038-2020
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.
Published May 27, 2020 · Recall initiated: April 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pega Medical Inc.
- Distributor
- US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
- Lot
- SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Canada
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