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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 TRIAL see related information
Date Initiated by Firm January 29, 2018
Create Date March 28, 2018
Recall Status1 Completed
Recall Number Z-1259-2018
Recall Event ID 79241
510(K)Number K162024  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500

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 Contact Teffany 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
Action DJO 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 Commerce 92 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KWS and Original Applicant = ENCORE MEDICAL, L.P
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