Recall Z-0380-2014 ยท HRS Plate, Fixation, Bone
Synthes USA HQ, Inc.
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
| Date | Nov 22, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw. |
| Root cause | Labeling mix-ups |
| Action | Synthes sent an URGENT NOTICE: MEDICAL DEVICE RECALL letter dated July 31, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Nuber, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Fax the documents to Synthes at 1-8 |
| Quantity | 98 |
| Distribution | Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT. |
| 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 |