Ortho Solutions Recalls System 26 Implants Due to Corrosion Residue
Ortho Solutions is recalling 106 System 26 Forefoot and Midfoot implant trays from the US market because corrosion residue was found inside the cannulated devices.
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: The recall is classified as FDA Class II, and the hazard involves corrosion residue in medical implants, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho Solutions, Ltd. is recalling 106 System 26 Forefoot and Midfoot Implants and Instruments trays from the United States market. The recall was initiated after the company identified corrosion residue inside the cannulated devices contained in the Forefoot and Midfoot trays.
The affected products include specific part numbers ranging from OS900035-NS to OS900059-NS. The recall covers specific lot numbers, including 1088402, 1088403, and others listed in the agency record. The total quantity of units involved in this recall is 120.
Consumers and healthcare providers who have these specific trays should stop using them and contact Ortho Solutions for further instructions on how to return or dispose of the affected devices.
The recalled product
- Product
- SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS…
- Manufacturer
- ORTHO SOLUTIONS, LTD.
- Hazard
- Affected units
- 120
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 (20)
- Lot Numbers: 1088402
- 1088403
- 1088404
- 1088405
- 1088406
- 1091608
- 1091646
- 1091648
- 1091628
- 1088393
- 1091658
- 1088394
- 1091586
- 1088395
- 1091598
- 1088396
- 1088397
- 1091623
- 1088398
- 1091618
Distribution
Distribution scope not specified by the agency.
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