Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1709-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: April 18, 2016

Date Posted: June 1, 2016

Recall Number: Z-1709-2016

Event ID: 73945

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.

Status: Terminated

Product Quantity: 7363 units

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated