djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Reported: August 15, 2012 Initiated: July 16, 2012 #Z-2146-2012
Product Description
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 18 devices
- Distribution
- Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair. Recalled by Encore Medical, Lp. Units affected: 18 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2146-2012.
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