Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving incorrect surgical guidance information marked on bone fixation implants used in foot and ankle procedures. The labeling error constitutes a risk-of-harm for a surgical device where no injuries have yet been reported.
Plain-English summary
Wright Medical Technology, Inc. is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants, which are devices used for bone stabilization and fixation. The affected devices contain incorrect dorsiflexion descriptions that are laser marked on the parts.
Two lots are involved in this recall, affecting 50 units total. The recalled devices carry Lot Number 1737413 and UDI/DI 00889797101035. These units were distributed nationwide throughout the United States.
The FDA has classified this as a Class II medical device recall based on the marking discrepancy identified on these surgical implants.
The recalled product
- Product
- stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- 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 (2)
- UDI/DI 00889797101035
- Lot Number 1737413
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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