🔍 RecallPedia

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

Class I - Dangerous
🏥 Medical Devices Recalled: June 3, 2022 SAFE ORTHOPAEDICS Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
SAFE ORTHOPAEDICS LLC
Reason for Recall:
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

Product Codes/Lot Numbers:

KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.

Distribution:

Distributed in: MD

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1572-2022