DeRoyal Recalls Ortho Total Joint Tracecart Kits Due to Sterilization Concerns
DeRoyal Industries is recalling 87 units of GEO-MED ORTHO TOTAL JOINT TRACECART kits because they contained Stryker togas with a potential sterilization problem.
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 a potential sterilization failure in a medical device used for general surgery, which poses a risk of harm even without reported injuries.
Plain-English summary
DeRoyal Industries Inc is recalling 87 units of the GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07. This product is a non-sterile kit intended for general surgical use and is available by prescription only.
The recall was initiated because the kits contained Stryker togas that were previously recalled for a potential problem with sterilization. The affected units were distributed nationwide in the United States, specifically within the state of Pennsylvania.
Healthcare facilities and consumers should stop using the affected kits immediately. Specific serial numbers for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 87
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)
- Serial Numbers: 25405311
- 25405485
- 25556398
- 25866038
- 25920479
- 25969803
- 26040887
- 26092011
- 26092089
- 26109451
- 26198457
- 26262324
- 26330892
- 26394079
- 26568438
- 26637085
- 26695568
- 26938574
- 26942371
- 26946478
Distribution
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