00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots distributed from lot 69998600 (2/20/1996) to present
- 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:
- Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Product Codes/Lot Numbers:
All lots distributed from lot 69998600 (2/20/1996) to present
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0398-2013
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.