Events

Recall of Bit, Drill

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73945
  • Event Risk Class
    Class 2
  • Event Number
    Z-1709-2016
  • Event Initiated Date
    2016-04-18
  • Event Date Posted
    2016-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145519
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bit, drill - Product Code HTW
  • 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.
  • 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.

Device

Bit, Drill
  • Model / Serial
    Catalog ID 03.010.060S Lot # 5558809, 6204324, 6813586, 7648837, 5559839, 6214366, 6818438, 7648838, 5575915, 6235676, 6827807, 7657752, 5579717, 6240287, 6830470, 7657753, 5582298, 6247514, 6835634, 7660380, 5585788, 6249834, 6841962, 7661528 5594237, 6269336, 6851101, 7661529, 5594238, 6276953, 6857546, 7674414, 5616439, 6279756, 6860704, 7687319, 5633067, 6279757, 6870563, 7693164, 5656914, 6302746, 6873394, 7716604, 5672506, 6313568, 6873396, 7731690 5682043, 6313569, 6898040, 7739027, 5692087, 6325420, 6904377, 7753584, 5702206, 6331923, 6908328, 7766654, 5711966, 6334954, 6919278, 7774127, 5724637, 6339936, 6925232, 7774128, 5727691, 6348925, 6931055, 7794479 5732158, 6355191, 6939080, 7817283, 5741332, 6368986, 6949503, 7830606, 5748361, 6375334, 6961056, 7835732, 5760640, 6382329, 6967764, 7848333, 5772367, 6398746, 6975982, 7869029, 5780654, 6413506, 6984973, 7870629 5782800, 6420887, 6996252, 7894923, 5782801, 6433683, 7004816, 7899079, 5782802, 6433684, 7013143, 7903010, 5794181, 6438144, 7019693, 7908522, 5816780, 6449832, 7029024, 7918012, 5818769, 6458079, 7036198, 7919639 5818770, 6464443, 7052563, 7924989, 5829138, 6475737, 7064072, 7941743, 5847359, 6480417, 7070681, 7947278, 5860702, 6486376, 7084937, 7963626, 5861834, 6488940, 7275546, 7981633, 5861836, 6505811, 7304754, 7993351 5870708, 6509276, 7349355, 9808655, 6010554, 6528479, 7359254, 9820617, 6031951, 6540263, 7371663, 9825386, 6034093, 6549146, 7382623, 9826363, 6034128, 6557658, 7400014, 9831036, 6051790, 6563112, 7400015, 9841499 6052762, 6572199, 7400016, 9855040, 6055036, 6577880, 7416878, 9859105, 6066429, 6586607, 7422660, 9864677, 6069150, 6593553, 7441691, 9869742, 6069151, 6598206, 7444103, 9878216, 6074684, 6603184, 7460590, 9886333 6080184, 6610704, 7465210, 9904888, 6081960, 6621162, 7476937, 9911126, 6091446, 6636693, 7485616, 9915461, 6092777, 6655352, 7497778, 9924572, 6109266, 6674053, 7499940, 9932287, 6121870, 6686555, 7512119, 9939768 6124816, 6707678, 7520264, 9959608, 6130838, 6721722, 7533286, 9961574, 6133623, 6733633, 7544212, 9970453, 6136836, 6752258, 7554690, 9985425, 6141455, 6761019, 7563621, H023093, 6153365, 6766654, 7636777, H024812 6163583, 6777654, 7636778, H034525, 6186051, 6786129, 7636779, H039109, 6186052, 6796018, 7648835, 6187891, 6796019, 7648836
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product Description
    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 Femoral Nails (ALFN).
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA