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U.S. Department of Health and Human Services

Class 2 Device Recall djosurgical Linear Neck Trials with Spring Sides

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  Class 2 Device Recall djosurgical Linear Neck Trials with Spring Sides see related information
Date Initiated by Firm July 10, 2018
Create Date April 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-1692-2020
Recall Event ID 85211
510(K)Number K120241  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
Code Information All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Ms. Teffany Hutto
512-834-6255
Manufacturer Reason
for Recall		 The retaining ring on the neck trials has a potential to fail interoperatively.
FDA Determined
Cause 2		 Process design
Action The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall.
Quantity in Commerce 28 (14 REF S200635 and 14 S200636)
Distribution Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government 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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ENCORE MEDICAL, L.P.
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