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U.S. Department of Health and Human Services

Class 2 Device Recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL

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 Class 2 Device Recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIALsee related information
Date Initiated by FirmJanuary 29, 2018
Create DateMarch 28, 2018
Recall Status1 Completed
Recall NumberZ-1260-2018
Recall Event ID 79241
510(K)NumberK162024 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information ContactTeffany Hutto
512-834-6255
Manufacturer Reason
for Recall		It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
FDA Determined
Cause 2		Device Design
ActionDJO Global sent an Urgent Field Safety Notice letter dated January 29, 2018, to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call (512) 834-6255
Quantity in Commerce93 units
DistributionUS Nationwide Distribution
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.
510(K) Database510(K)s with Product Code = KWS
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