Zimmer Manufacturing Recalls Specific Lots of Sterile Hip and Trauma Implant Screws
Zimmer Manufacturing B.V. is recalling 99 units of sterile Hip and Trauma Implant Screws due to a potential small hole in the inner tray.
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 potential breach of sterile packaging for medical devices, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 99 units of sterile Hip and Trauma Implant Screws, specifically the periarticular plating system cancellous bone screw (partially threaded, hex head, 4.0 mm diameter, 16 mm length, catalog number 47234702116). The recall involves lot number 63146423.
The recall is being issued because a small hole may be present in the inner tray of the sterile packaging for these specific lots. This defect could potentially compromise the sterility of the medical devices.
The affected products were distributed worldwide, including in the United States, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, the UK, Sweden, and Canada. Healthcare providers and patients should stop using the affected lots and contact Zimmer Manufacturing B.V. for further instructions.
The recalled product
- Product
- Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 99
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: 63146423
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Zimmer Manufacturing B.V. 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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