Recalls / —
—#204615
Product
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
- FDA product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K152217
- Affected lot / code info
- a) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654
Why it was recalled
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Root cause (FDA determination)
Packaging change control
Action the firm took
Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
Recalling firm
- Firm
- Exactech, Inc.
- Address
- 2320 Nw 66th Ct, Gainesville, Florida 32653-1630
Distribution
- Distribution pattern
- US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
Timeline
- Recall initiated
- 2023-11-21
- Posted by FDA
- 2024-01-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #204615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.