PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 R This device is indicated for patients with severe knee pain and disability¿
Class I - DangerousWhat Should You Do?
- Check if you have this product: 00-5930-040-01 61774223 00-5930-040-01 61780003 00-5930-040-01 61774226 00-5930-040-01 61774225 00-5930-040-01 11005139 00-5930-050-01 61774236 00-5930-050-01 11004031 00-5930-060-01 61774234 00-5930-070-02 61780002 00-5930-070-01 62139076 00-5930-080-02 61774216 00-5930-080-01 61774229 00-5930-080-01 61780004 00-5930-080-02 61785662 00-5930-080-02 61774215
- 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:
- The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 R This device is indicated for patients with severe knee pain and disability¿
Product Codes/Lot Numbers:
00-5930-040-01 61774223 00-5930-040-01 61780003 00-5930-040-01 61774226 00-5930-040-01 61774225 00-5930-040-01 11005139 00-5930-050-01 61774236 00-5930-050-01 11004031 00-5930-060-01 61774234 00-5930-070-02 61780002 00-5930-070-01 62139076 00-5930-080-02 61774216 00-5930-080-01 61774229 00-5930-080-01 61780004 00-5930-080-02 61785662 00-5930-080-02 61774215
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1051-2018
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.