Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray 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, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a packaging defect (hole in tray) that may compromise 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 50 units of ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screws, 3.5 mm hex head, 57 mm length (Catalog Number 00225305745). The recall affects Lot 63275969.
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 sterile integrity of the implant.
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 contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 50
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: 63275969
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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