Recall Z-0236-2016 ยท HRS Plate, Fixation, Bone
Synthes (USA) Products LLC
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
| Date | Nov 6, 2015 (initiated Oct 8, 2015) |
| Status | Terminated |
| Reason | The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use. |
| Root cause | No Marketing Application |
| Action | Synthes sent an Urgent Notice Medical Device Letter dated October 8, 2015. to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Autho |
| Quantity | 20,494 |
| Distribution | US Distribution to the states of :MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915818 | SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE Synthes (Usa), Jan 17, 1992 |