Exactech, Inc.: 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/ 320-4

Hazard

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

Details from the source

Reason for recall: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Distribution: 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. Quantity: 61,334 UNITS Lot/code info: 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

UPC codes

10885862086655, 10885862086662, 10885862086693, 10885862086709

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.