Zimmer Biomet Recalls Uniflex Humeral Nail Guide Pins Due to Packaging Error
Zimmer Biomet is recalling 22 units of Uniflex Humeral Nail guide pins because they may be packaged with the wrong combination of pins, potentially causing surgical delays or injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of iatrogenic fracture and surgical complications, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 22 units of the Uniflex Humeral Nail G-PIN 2.8BL 3.2PL 60 CM 2PK (Item Number 467265, Lot Number 662420). The product is intended to contain one Ball Tip Guide Pin and one Plain Tip Guide Pin. However, the packages may have been incorrectly filled with either two Ball Tip Guide Pins and no Plain Tip Guide Pins, or two Plain Tip Guide Pins and no Ball Tip Guide Pins.
The affected units were distributed in the United States to Maryland, Texas, Florida, Georgia, Virginia, and Pennsylvania. If a surgeon uses a package with the incorrect combination of pins, they may have to implant the nail without the Plain Tip Guide Pin, ream with a Plain Tip Guide Pin, or choose not to ream the humeral canal. These scenarios can result in a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.
This recall is classified as Class II by the FDA. Healthcare providers should check their inventory for the specific item and lot numbers listed above and stop using the affected units.
The recalled product
- 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…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Number 467265 Lot Number 662420
Distribution
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