Zimmer Universal Locking System Cortical Screws Recalled for Packaging Defect
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.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging defect (hole in the inner tray) which poses a risk to sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 200 units of Zimmer Universal Locking System (ULS) 3.5 mm cortical screws, self-tapping, 18 mm length (Lot 63297474). The recall is due to a potential defect where a small hole may be present in the inner tray of the sterile packaging.
The affected product was 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 consumers should stop using the affected lots and contact Zimmer Manufacturing B.V. for further instructions or a return.
The recalled product
- Product
- Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 200
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: 63297474
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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Similar recalls
- ModerateZimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues
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