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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Pega Medical Inc.
- Reason for Recall:
- The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2038-2020
Related Recalls
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Pega Medical
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.