- Recalling firm
- DT MedTech, LLC
- Reason for recall
- Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
- Affected products (lot / model / serial)
- Lot: AACAA/ DI: B095302112
- Units affected
- 67 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
- Firm location
- Mcminnville, TN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2399-2026
- Recall initiated
- March 24, 2026
- FDA classification date
- June 10, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98987
- Last updated on HTM Vibe
- July 24, 2026