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Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK recallZ-0087-2017 · Zimmer Biomet, Inc. · initiated Aug 2, 2016

Class II Terminated All recalls posted in October 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Mixed-up of materials/components

What the company is doing

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" notification dated 8/2/2016 affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The consignees were instructed to review the notification and ensure affected team members are aware of the contents; immediately locate and quarantine affected product in your inventory; complete and return the Certification of Acknowledgment portion of Attachment-1 Inventory Return Certification Form via digital copy within three (3) days via email to [email protected] or via fax to 574-372-1683; Immediately return all affected product from your distributorship and affected hospitals within your territory; and retain a copy of your recall acknowledgement and product return form. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to [email protected].

Recall details

Recall number
Z-0087-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 2, 2016
Posted by the FDA
Oct 14, 2016
Recalling firm
Zimmer Biomet, Inc.
Quantity
22 units
Product code
HTY
FDA submissions
K831005
Distribution
US Distribution to states of: MD,TX, FL, GA, VA and PA.

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.

Code information (models, lots, serial numbers)

Item Number 467265 Lot Number 662420

Other devices under the same FDA submission

2 devices cleared under K831005 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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