Synthes, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1711-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.

Product Classification:

Class II

Date Initiated: May 13, 2015
Date Posted: June 10, 2015
Recall Number: Z-1711-2015
Event ID: 71277
Reason for Recall:

affected parts and lots of the Cannulated Drill Bits have the potential to break during use

Status: Terminated
Product Quantity: 1495 US (37 OUS)
Code Information:

Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated