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U.S. Department of Health and Human Services

Class 2 Device Recall Exprt Precision System

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 Class 2 Device Recall Exprt Precision Systemsee related information
Date Initiated by FirmSeptember 21, 2018
Create DateApril 10, 2019
Recall Status1 Terminated 3 on September 16, 2020
Recall NumberZ-1123-2019
Recall Event ID 82379
510(K)NumberK163497 
Product Classification Prosthesis, hip, constrained, cemented or uncemented, metal/polymer - Product Code KWZ
ProductExprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
Code Information All lots.
FEI Number 1000116912
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery
FDA Determined
Cause 2		Other
ActionOn 09/21/18, Urgent Field Safety Notices, updated surgical techniques, and Acknowledgement and Receipt Forms were emailed to Surgical Sales Agents. The Surgical Technique provides instructions on use of the manual T-handle as the primary tightening method. It also provides instructions for use of the torque wrench to ensure that the readout for the torque wrench is at "0" before torque is applied. Sales agents were asked to affirm that they have read and understood the updated Surgical Technique information provided in the Field Safety Notice Bulletin. They were also asked to affirm that they disseminated this information to all employed and contracted sales reps in their organization. On 01/29/19, Urgent Field Safety Notices were emailed to Surgical Agents. This notice communicated the exchange process for physical product in inventory. The firm will notify Surgical Agents to make arrangements for the exchange of affected inventory with proximal bodies that are packaged with new capture bolts containing a polyethene plug. Surgical Agents with additional questions were encouraged to call 512-834-6255.
Quantity in Commerce22
DistributionUS: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, NV,.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWZ
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