—#156193

Product

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K150890
Affected lot / code info: Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.

Why it was recalled

Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at kaya@exac.com or 800-392-2832.

Recalling firm

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

Distribution

Distribution pattern: CA and NY.

Timeline

Recall initiated: 2017-04-07
Posted by FDA: 2017-06-19
Terminated: 2020-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.