| Class 2 Device Recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL | |
Date Initiated by Firm | January 29, 2018 |
Create Date | March 28, 2018 |
Recall Status1 |
Completed |
Recall Number | Z-1256-2018 |
Recall Event ID |
79241 |
510(K)Number | K162024 |
Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
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Product | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380
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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWS
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