Recall Z-0167-2016 ยท HRS Plate, Fixation, Bone
Synthes (USA) Products LLC
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
| Date | Oct 30, 2015 (initiated Oct 6, 2015) |
| Status | Terminated |
| Reason | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. |
| Root cause | Packaging |
| Action | Synthes sent an URGENT NOTICE: MEDICAL DEVICE NOTIFICATION UPDATED INFORMATION: CORRECTED LOT NUMBER SS 2.7mm Locking Screw, self-tapping letter dated January 13, 2014, to the affected 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 Authoriza |
| Quantity | 98 |
| Distribution | US Distribution to the state of : TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063049 | SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM Synthes (Usa), Dec 18, 2006 |