Zimmer Biomet Recalls T7 Driver Solid AO Due to Fracture Risk
Zimmer Biomet is recalling 1,924 T7 Driver Solid 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 criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,924 units of the T7 Driver Solid AO (Part Number 110018541). This medical device is used in conjunction with Biomet Headless Compression Screws and Twist-Off Screws for the fixation of bone fractures, joint fusion, or bone reconstruction in the foot and hand.
The recall was initiated because there is a potential for the driver to fracture, bend, or shear. The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, Costa Rica, Malaysia, the Netherlands, and Singapore.
Healthcare providers and patients should stop using the affected T7 Driver Solid AO units and contact Zimmer Biomet for further instructions. The recall covers specific lot numbers listed in the agency's official documentation.
The recalled product
- Product
- T7 Driver Solid AO (Part Number 110018541) 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
- 1,924
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.
See all 2 products in this recall →Related recalls
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