Zimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole
Zimmer Manufacturing B.V. is recalling specific lots of 2.7 mm Cortical Screws because a small hole may be present in the inner tray of the sterile packaging.
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 involves a packaging defect (hole in the tray) which poses a risk to sterility, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 100 units of Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length (Lot 63292596). 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 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 check their inventory for this specific lot number. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to standard recall procedures.
The recalled product
- Product
- Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 100
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: 63292596
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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