—#176515

Product

Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.

FDA product code: LRN — Wire, Surgical
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 321-52-06, All Serial Numbers

Why it was recalled

Potential for the wire to fracture at the threads and remain in the glenoid.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Exactech notified customers of the recall on about 09/10/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that Exactech had received reports of the 3.2mm K-Wire fracturing at the threads and remaining in the glenoid. Instructions included to immediately cease distribution of or use of the product, provide the recall information to accounts that may have the affected product in their possession, identify and quarantine any affected products in inventory, and complete and return the attached Recall Acknowledgement Form and Recall Inventory Response form to Exactech via email at recalls@exac.com.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.

Timeline

Recall initiated: 2019-09-10
Terminated: 2023-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176515. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.