Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100
Class I - DangerousWhat Should You Do?
- Check if you have this product: All product manufactured prior to January 2014.
- 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:
- Zimmer Biomet, Inc.
- Reason for Recall:
- Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100
Product Codes/Lot Numbers:
All product manufactured prior to January 2014.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0299-2020
Related Recalls
Device has the potential for fracture during use.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.