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Recall Observatory FDA recall evidence

Device product

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

Z-2562-2025

August 15, 2025

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 97459
Status
Ongoing
Classification
Class II
Quantity
11,542 units
Official record key
device-enforcement:Z-2562-2025

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: 322-38-00/UDI:10885862593832, REF: 322-38-03/UDI:10885862593849, REF: 322-42-00/UDI: 10885862593917, REF:322-42-03/UDI:10885862593924

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

    reason.no_named_rule · v1.0.0

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