Recall Z-0792-06 ยท JEY Plate, Bone
Synthes (USA)
Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
| Date | Apr 26, 2006 (initiated Mar 30, 2006) |
| Status | Terminated |
| Reason | Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile. |
| Root cause | Other |
| Action | Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06. |
| Quantity | 3511 |
| Distribution | Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.