Z-0087-2017Class II

Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin...

Name: Z-0087-2017 Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin...
Creator: Zimmer Biomet, Inc.
Published: 2016-08-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-08-02 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2016-08-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0087-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Posted: 2016-10-14
Terminated: 2017-03-24
Recalling firm: Zimmer GmbH
Product: 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 code: HTY Pin, Fixation, Smooth
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.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: 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].
Quantity in commerce: 22 units
Distribution: US Distribution to states of: MD,TX, FL, GA, VA and PA.
Product codes and lots: Item Number 467265 Lot Number 662420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0087-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0087-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-14

Product code HTY

K831005Class IIWire & Steinman PinsKirschner Medical Corp. / cleared 1983-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)