Device product
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
Z-2561-2025
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 97459
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61,334 UNITS
- Official record key
device-enforcement:Z-2561-2025
Official wording
Reason: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Code information: All Serial Numbers, REF: 320-38-00/UDI:10885862086655 REF: 320-38-03/UDI: 10885862086662 REF: 320-42-00/UDI: 10885862086693 REF: 320-42-03/UDI: 10885862086709
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.
Derived failure modes
-
Unknown
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.