PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006
- 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:
- Synthes (USA) Products LLC
- Reason for Recall:
- These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
Product Codes/Lot Numbers:
Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006
Distribution:
Distributed in: US, TX, LA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1383-2017
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