djo surgical Screw 6.5 mm recall: Labeling Error
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Why was djo surgical Screw 6.5 mm recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 007A1037, Ref 010-55-25.
- Product
- djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
- Recalling firm
- Encore Medical, Lp
- Quantity
- 18 devices
- Distribution
- Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
- Recall date
- August 15, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)