Multipolar Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar Bipolar C
FDA device recall Z-0410-2013 · posted 2012-11-20 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer Inc. is initiating a removal of the Multipolar Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
- Action taken
- Zimmer sent an Urgent Medical Device Recall letter to all affected consignees during the week of September 3, 2012. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, quarantine the recalled product and return remaining inventory. Customers were advised to complete Inventory Return Certification form attached.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 195
- Distribution
- Worldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Kor
- Date initiated
- 2012-08-31
- Date posted
- 2012-11-20
- Date terminated
- 2013-09-23
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIPOLAR HIP DEVICE (K833991) | Zimmer | 1984-01-30 |