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 Femoral Nails (ALFN).

Recall number

Z-1709-2016

Recalling firm

Synthes (USA) Products LLC

Product

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).

Status

Terminated

Initiated

2016-04-18

Posted

2016-05-23

Terminated

2017-02-02

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

HTW

Firm FEI

3008812560

Firm city

West Chester

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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