3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product 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 Femoral Nails (ALFN).
FDA Recall Z-1710-2016 · Posted 2016-05-23
Advertisement
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHTW
Date Initiated2016-04-18
Date Terminated2017-02-02
Product Quantity1274 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement