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U.S. Department of Health and Human Services

Class 2 Device Recall djo surgical6.5 mm cancellous bone screw

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 Class 2 Recall
djo surgical6.5 mm cancellous bone screw
see related information
Date Posted August 06, 2012
Recall Status1 Terminated on December 04, 2012
Recall Number Z-2146-2012
Recall Event ID 62561
Premarket Notification
510(K) Number
K931665 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Code Information Lot 007A1037, Ref 010-55-25.
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Teffany Hutto
512-832-9500
Manufacturer Reason
for Recall
One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.
Quantity in Commerce 18 devices
Distribution Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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 = HWC and Original Applicant = ENCORE ORTHOPEDICS, INC.
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