PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item No. 00-5901-032-00 Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774
- 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.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Product Codes/Lot Numbers:
Item No. 00-5901-032-00 Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1696-2015
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.