Ankle Implant Recall
DT MedTech, LLC is recalling the Hintermann Series Talar Implant, Left, Size 2 REF 302112 because left implant packaging and labeling bear a right implant device. The recall involves 67 units distributed worldwide, including the United States (CA, AR, AZ, ID) and the countries of PER, KOR. The recall number is Lot AACAA/ DI: B095302112.
| Brand | DT MedTech, LLC |
|---|---|
| Product | Hintermann Series Talar Implant, Left, Size 2 REF 302112 |
| Reason | Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device. |
| Severity | moderate |
| Units affected | 67 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your surgeon or implant center to confirm whether your device matches the recalled lot AACAA/ DI: B095302112.
- If affected, do not use the device and follow your surgeon's instructions regarding removal or replacement.
- Keep all packaging and recall communications for reference.
- Await further instructions from the FDA or manufacturer.
How to identify the recalled item
| Lot / date codes | Lot: AACAA/ DI: B095302112 |
|---|---|
| Lot / date codes | Lot: AACAA/ DI: B095302112 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.