Zimmer Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0087-2017)

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:

Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.

Product Classification:

Class II

Date Initiated: August 2, 2016

Date Posted: October 26, 2016

Recall Number: Z-0087-2017

Event ID: 75229

Reason for Recall:

The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.

Status: Terminated

Product Quantity: 22 units

Code Information:

Item Number 467265 Lot Number 662420

Distribution Pattern:

US Distribution to states of: MD,TX, FL, GA, VA and PA.

Voluntary or Mandated:

Voluntary: Firm initiated