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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number 467265 Lot Number 662420
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer Biomet, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
Item Number 467265 Lot Number 662420
Distribution:
Distributed in: US, MD, TX, FL, GA, VA, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0087-2017
Related Recalls
Device has the potential for fracture during use.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.