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Terminated

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

FDA Recall Z-1459-2015 · Posted 2015-04-20

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2015-02-13
Date Terminated2016-09-29
Product Quantity112 devices

Reason for Recall

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

Firm Action

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.

Root Cause

Labeling mix-ups

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042021EXACTECH EQUINOXE SHOULDER SYSTEMExactech, Inc. · 2004-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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