Recall Z-1457-2014 ยท GAD Retractor
Synthes, Inc.
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
| Date | Apr 15, 2014 (initiated Feb 11, 2014) |
| Status | Terminated |
| Reason | The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22. |
| Root cause | Error in labeling |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450. |
| Quantity | 20 |
| Distribution | Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.