—#167190

Product

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K063569
Affected lot / code info: Serial Numbers: 5214432, 5214445

Why it was recalled

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions: " 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 attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.

Recalling firm

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

Distribution

Distribution pattern: In the countries of Australia and France

Timeline

Recall initiated: 2018-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167190. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.