• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DJO Surgical

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall DJO Surgical see related information
Date Initiated by Firm September 19, 2018
Create Date July 27, 2019
Recall Status1 Open3, Classified
Recall Number Z-2090-2019
Recall Event ID 83037
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Code Information Lot # 262667L01
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Teffany Hutto
Manufacturer Reason
for Recall
Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 9/19/2018 the firm emailed an "Urgent Field Safety Notice" letter to their consignees. The Field Safety Notice letter asked the customers to do the following: 1.Contact their customer service to request a RMA for return and exchange. 2.If the customer does not have the drill shaft or the number of sets identified, please contact Joan Busick at andra.busick@djdoglobal.com. 3. If the customer has questions they should contact Teffany Hutto by phone at (512) 834-6255.
Quantity in Commerce 21
Distribution US ( MS, NY, MO, OK, UT, AZ)
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.