Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1710-2016)

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 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).

Product Classification:

Class II

Date Initiated: April 18, 2016

Date Posted: June 1, 2016

Recall Number: Z-1710-2016

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: 1274 units

Code Information:

Catalog ID 03.010.100S Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051 5575918, 6199232, 6676406, 5603463, 6231850, 6721724 5649117, 6256560, 6734876, 5668880, 6305842, 6808463 5724639, 6319050, 6831468, 5742276, 6320150, 6997294 5807341, 6343980, 7039877, 6012770, 6401819, 7052565 6045597, 6448707, 7081479, 6057914, 6472100, 7378832 6108342, 6501856, 7410311, 6142443, 6503351, 7466207 7554670, 7620971, 7675571, 7711694, 7801251, 7918026 9815103, 9828932, 9905850, 9939769, H033348

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