Device product
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Z-1031-2017
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 75989
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
device-enforcement:Z-1031-2017
Official wording
Reason: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Code information: Serial No. 4507932-4507943; Catalog No. 138-36-29; UDI: 10885862024831
Distribution pattern: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Derived failure modes
-
Unknown
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.