Recall Z-0323-2016 ยท HWC Screw, Fixation, Bone
Synthes (USA) Products LLC
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
| Date | Nov 2, 2015 |
| Status | Terminated |
| Reason | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System). |
| Root cause | Process control |
| Action | Synthes sent an "URGENT FIELD SAFETY NOTIFICATION" letter dated November 2, 2015. Customers were asked to take the following actions: -Review the correct package insert (GP2615, attached). -If found, discard incorrect package insert associated with the locking screw noted in the table above. -Forward this Field Safety Notification to anyone in your facility that needs to be informed. -If the package insert has been forwarded to another facility, contact that facility. -Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telepho |
| Quantity | 229 |
| Distribution | Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012114 | SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM Synthes (Usa), Sep 28, 2001 |
| K040588 | SYNTHES (USA) 2.4 MM LCP WRIST PLATE Synthes (Usa), May 7, 2004 |
| K050110 | SYNTHES (USA) LCP MODULAR FOOT PLATES Synthes (Usa), Mar 4, 2005 |
| K063049 | SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM Synthes (Usa), Dec 18, 2006 |
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes (Usa), Dec 9, 2010 |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Synthes (Usa), Jan 21, 2011 |