Aesculap SIBD Trial Implants Recalled for Incorrect Part Number Etching
Aesculap Implant Systems LLC is recalling 5 SIBD trial implants because the part numbers etched on the instruments may be incorrect, potentially causing selection errors.
What this means for you
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, but the hazard is limited to a labeling error (incorrect part number etching) on instruments that are correctly dimensioned, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Aesculap Implant Systems LLC is recalling five Aesculap SIBD 4 degree Trial Implants (SJ768T-US) and Aesculap SIBD 9 degree Trial Implants (SJ780T-US). These instruments are used by surgeons to assist in selecting the correct size implant for a patient. The recall is due to a labeling error where the part number etched on the instrument may not match the actual instrument. Specifically, the 4 degree trial instrument may be marked with the part number for the 9 degree instrument, and the 9 degree trial instrument may be marked with the part number for the 4 degree instrument.
The instruments are correctly dimensioned, meaning the physical size and angle are accurate, but the identification marking is potentially wrong. This discrepancy could lead to confusion during surgical planning or implant selection. The affected units were distributed nationwide in the United States, including Colorado, Ohio, Oklahoma, and Texas.
Healthcare providers and consumers should stop using these specific trial implants if they match the described part numbers and contact Aesculap Implant Systems LLC for instructions on replacement or return. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 5
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)
- 4 degree - SJ768T-US and 9 degree SJ780T-US
Distribution
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