Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0681-2017)

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:

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Product Classification:

Class II

Date Initiated: November 1, 2016

Date Posted: December 7, 2016

Recall Number: Z-0681-2017

Event ID: 75694

Reason for Recall:

Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

Status: Terminated

Product Quantity: 84 units

Code Information:

Model/Catalog # 316.15 Lot/Serial Number U172728

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated