Recall Z-1709-2016 ยท HTW Bit, Drill
Synthes (USA) Products LLC
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral F
| Date | May 23, 2016 (initiated Apr 18, 2016) |
| Status | Terminated |
| Reason | The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier. |
| Root cause | Device Design |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Letter dated April 19, 2016 to customers. The identified the affected product, problem and actions to be taken. The letter instructed customers to examine their inventory to determine if they currently have the affected product. Customers were asked to complete and return the Verification Section of the recall notification letter. For questions call 610-719-5450. |
| Quantity | 7363 units |
| Distribution | US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.