3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bit

FDA device recall Z-1709-2016 · posted 2016-05-23 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HTW

Quantity affected

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,

Date initiated

2016-04-18

Date posted

2016-05-23

Date terminated

2017-02-02

Location

West Chester, PA