Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present 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 defect in the sterile packaging of an implanted medical device. While no specific injuries or illnesses are reported in the source text, the risk of harm from a compromised sterile implant is significant, 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 specific lots of sterile Hip and Trauma Implant Screws. The recall involves 3,955 units of Zimmer Plates and Screws (ZPS), including various 4.0 mm, 4.5 mm, and 6.5 mm cancellous and cortical screws.
The recall is being issued because a small hole may be present in the inner tray of the affected sterile packaging. The source text does not specify the exact nature of the risk associated with the hole, such as whether it compromises sterility or leads to device failure.
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 facilities should check their inventory for the specific lot numbers listed in the official recall notice and stop using the affected devices.
The recalled product
- Product
- Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 3,955
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.
See all 12 products in this recall →Related recalls
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