Recalls / —

—#134561

Product

Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.

FDA product code

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K042021

Affected lot / code info

Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.

Why it was recalled

Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice.

Recalling firm

Firm

Exactech, Inc.

Address

2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.

Timeline

Recall initiated

2015-02-13

Posted by FDA

2015-04-20

Terminated

2016-09-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #134561. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.