Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; Biomet Spine, 100 Interpace Parkway, Parsippany
FDA device recall Z-2300-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- Reason for recall
- Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Action taken
- The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 112
- Distribution
- Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan,
- Date initiated
- 2009-04-02
- Date posted
- 2009-09-22
- Date terminated
- 2009-09-23
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EBI 5.5 HELICAL FLANGE SPINAL SYSTEM (K061441) | Ebi, L.P. | 2006-07-25 |