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U.S. Department of Health and Human Services

Class 2 Device Recall EXACTECH EQUINOXE SHOULDER SYSTEMEquinoxe Humeral Head, Short, 44mm

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 Class 2 Device Recall EXACTECH EQUINOXE SHOULDER SYSTEMEquinoxe Humeral Head, Short, 44mmsee related information
Date Initiated by FirmFebruary 13, 2015
Date PostedApril 20, 2015
Recall Status1 Terminated 3 on September 29, 2016
Recall NumberZ-1459-2015
Recall Event ID 70722
510(K)NumberK042021 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductEquinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Code Information Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactGraham L. Cuthbert
352-327-4613
Manufacturer Reason
for Recall		Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
FDA Determined
Cause 2		Labeling mix-ups
ActionExactech 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.
Quantity in Commerce112 devices
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWS
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