Recall Z-2146-2012 ยท HWC Screw, Fixation, Bone
Encore Medical, Lp
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
| Date | Aug 6, 2012 (initiated Jul 16, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 18 devices |
| Distribution | Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931665 | 6.5 MM CANCELLOUS BONE SCREW Encore Orthopedics, Inc., Feb 17, 1994 |