—#184468

Product

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

FDA product code: HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042021
Affected lot / code info: Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407.

Why it was recalled

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Root cause (FDA determination)

Employee error

Action the firm took

Exactech distributed the recall notice titled, "URGENT PRODUCT RECALL NOTICE" to consignees in possession of affected inventory in the US and Australia on November 9, 2020 via email. In order to comply with the notice, 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 attached Recall Inventory Response Form to Exactech.

Recalling firm

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

Distribution

Distribution pattern: Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

Timeline

Recall initiated: 2020-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.