Wright Medical Recalls PRO-STIM Injectable Due to Sterility Documentation Issues
Wright Medical Technology is recalling 19 units of PRO-STIM 10cc Injectable because adequate documentation confirming sterility was missing.
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 explicitly states the issue is a lack of documentation confirming sterility without reporting any illnesses or injuries. Per the rubric, this fits the criteria for a voluntary precautionary recall or low-risk contamination where harm has not been reported, placing it at Moderate severity.
Plain-English summary
Wright Medical Technology, Inc. is recalling 19 units of PRO-STIM 10cc INJECTABLE, Part Number 86SR0410, Lot Number 1564697. The recall was initiated because the firm discovered a lack of adequate documentation confirming sterility on these specific products.
The affected units were distributed in the US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these devices.
Consumers and healthcare providers who have these specific units should contact Wright Medical Technology, Inc. for further instructions on how to handle the recalled product.
The recalled product
- Product
- PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
- Manufacturer
- Wright Medical Technology, Inc.
- Category
- Medical Device — Injectable
- Hazard
- Affected units
- 19
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 1564697
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.
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