Zimmer Biomet Recalls 20mm Compress Device Short Anchor Plug
Zimmer Biomet is recalling 6 units of the 20mm Compress Device Short Anchor Plug due to potential metal burrs that may prevent proper insertion of drill and transverse pins.
What this means for you
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 medical device with a defect that could prevent proper surgical insertion, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 6 units of the Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant (Item number: 178562). The recall is due to potential metal burrs in the holes of the device, which may prevent the appropriate drill and transverse pins from being inserted.
The affected units are identified by Lot Number 608740 and UDI Number (01)00880304461666(17)271113(10)608740. The devices were distributed nationwide in the states of Indiana, Maryland, and the District of Columbia. The Compress Segmental Femoral Replacement System components are intended for uncemented use only.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions. Consumers are not expected to have these devices in their possession, as they are medical implants used for specific surgical procedures such as revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, and trauma.
The recalled product
- Product
- Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously fai
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 6
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)
- Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740
Distribution
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