Ossur J Tong Sterile Medical Device Recall for Labeling Error
Ossur Americas is recalling 138 units of J Tong sterile medical devices because the titanium pin label incorrectly lists a ceramic tip.
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 involves a labeling error and confirmatory testing without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ossur Americas is recalling 138 units of J Tong sterile medical devices, including specific assemblies and component trays. The recall involves all lots of these products manufactured between June 30, 2009, and December 13, 2018. The devices were distributed to facilities in 30 U.S. states and in Australia, Germany, New Zealand, and Belgium.
The recall was initiated because the second line of the description on the titanium pin label mistakenly lists a ceramic tip. The correct description should state titanium pin. Additionally, Halo system products labeled as MR conditional will undergo confirmatory safety testing to verify their MR conditional parameters.
Healthcare facilities and consumers who possess these specific J Tong sterile devices should stop using them and contact Ossur Americas for further instructions regarding the labeling correction and safety testing.
The recalled product
- Product
- Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY
- Manufacturer
- Ossur Americas
- Hazard
- Affected units
- 138
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)
- All lots of the products manufactured from 06/30/2009 - 12/13/2018
Distribution
Part of a larger recall action
This product is one of 8 recalled by Ossur Americas 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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