Wright Medical Recalls Ortholoc 3DI Locking Screws Due to Sterility Documentation Issues
Wright Medical Technology is recalling 40 units of Ortholoc 3DI locking screws because documentation confirming sterility was inadequate.
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, and the source text explicitly states the issue is a lack of documentation confirming sterility rather than a confirmed contamination or injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 40 units of the ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile (Part Number 58S03538). The recall was initiated after the firm discovered a lack of adequate documentation confirming the sterility of these specific products.
The affected products, identified by Lot Number 1568030, were distributed in the United States and several international locations, including Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain.
Consumers and healthcare providers should stop using the affected locking screws and contact Wright Medical Technology for further instructions or a replacement.
The recalled product
- Product
- ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 40
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 1568030
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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