Wright Medical Recalls Tibial Stem Components Due to Sterility Documentation Issues
Wright Medical Technology is recalling 65 units of INBONE STEM, TIBIAL, TOP components because adequate documentation confirming sterility was not found.
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, but the source text identifies the issue as a lack of documentation rather than a confirmed defect or reported injury, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 65 units of INBONE STEM, TIBIAL, TOP, Part Number 200011901. The recall was initiated after the firm discovered a lack of adequate documentation confirming the sterility of these specific products.
The affected products are identified by Lot Number 1540433. These medical devices were distributed in the United States and in several international locations, including Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain.
This is a Class II recall. Consumers and healthcare providers should contact Wright Medical Technology for further instructions regarding the return or replacement of these units.
The recalled product
- Product
- INBONE STEM, TIBIAL, TOP, Part Number 200011901
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 65
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 Number 1540433
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by Wright Medical Technology, Inc. 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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