| Date Initiated by Firm |
August 02, 2016 |
| Date Posted |
October 14, 2016 |
| Recall Status1 |
Terminated 3 on March 24, 2017 |
| Recall Number |
Z-0087-2017 |
| Recall Event ID |
75229 |
| 510(K)Number |
K831005
|
| Product Classification |
Pin, fixation, smooth - Product Code HTY
|
| 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. |
| Code Information |
Item Number 467265 Lot Number 662420 |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact |
Customer Service
800-348-2759
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 CPWARFieldAction@zimmerbiomet.com 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 CPWARFieldAction@zimmerbiomet.com. |
| Quantity in Commerce |
22 units |
| Distribution |
US Distribution to states of: MD,TX, FL, GA, VA and PA. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = HTY and Original Applicant = KIRSCHNER MEDICAL CORP.
|
