Zimmer Biomet Recalls T7 Driver Cannulated AO Due to Fracture Risk
Zimmer Biomet is recalling 5,885 T7 Driver Cannulated AO units because they may fracture, bend, or shear during use.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential mechanical failure.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,885 units of the T7 Driver Cannulated AO (Part Number 110018531). The recall is due to a potential for the driver to fracture, bend, or shear. The product is a medical device used for the fixation of bone fractures, fusion of a joint, or bone reconstruction in the foot and hand.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Canada, Costa Rica, Malaysia, the Netherlands, and Singapore. The recall covers specific lot numbers, including 13422A, 13869A, and 13870A, among others.
Healthcare providers and consumers should stop using the affected T7 Driver Cannulated AO units and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 5,885
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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