Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers l9B0570; 19B0572
- 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:
- Medicrea International
- Reason for Recall:
- Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Product Codes/Lot Numbers:
Lot Numbers l9B0570; 19B0572
Distribution:
Distributed in: OH, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1156-2020
Related Recalls
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Medicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Medicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.