djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fractur
FDA device recall Z-2146-2012 · posted 2012-08-06 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 18 devices
- Distribution
- Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
- Date initiated
- 2012-07-16
- Date posted
- 2012-08-06
- Date terminated
- 2012-12-04
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6.5 MM CANCELLOUS BONE SCREW (K931665) | Encore Orthopedics, Inc. | 1994-02-17 |