Z-1710-2016Class II

3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile

Name: Z-1710-2016 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile
Creator: Synthes (USA) Products LLC
Published: 2016-04-18
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-04-18 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of 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... on 2016-04-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1710-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-18
Posted: 2016-05-23
Terminated: 2017-02-02
Recalling firm: Synthes (USA) Products LLC
Product: 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 code: HTW Bit, Drill
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.
Root cause tag: design
FDA 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 in commerce: 1274 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1709-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-23
Z-1710-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-23

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)