Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Met
FDA device recall Z-0094-2015 · posted 2014-10-20 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- The affected products are missing polar boss threads.
- Action taken
- Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 5:00pm EST.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 19
- Distribution
- Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
- Date initiated
- 2014-10-01
- Date posted
- 2014-10-20
- Date terminated
- 2015-03-02
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM (K091508) | Zimmer, Inc. | 2009-09-11 |