—#184116

Product

Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K092900, K101909
Affected lot / code info: Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432

Why it was recalled

The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

Root cause (FDA determination)

Process control

Action the firm took

The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020. Consignees have been instructed to: -Immediately cease distribution or use of this product -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the Recall Inventory Response Form to Exactech.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.

Timeline

Recall initiated: 2020-09-25
Terminated: 2023-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184116. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.