djo surgical Screw 6.5 mm, Sz 25mm, low profile recallZ-2146-2012 · Encore Medical, Lp · initiated Jul 16, 2012
Class II Terminated All recalls posted in August 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-2146-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 16, 2012
- Posted by the FDA
- Aug 6, 2012
- Recalling firm
- Encore Medical, Lp
- Quantity
- 18 devices
- Product code
- HWC
- FDA submissions
- K931665
- Distribution
- Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
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
Code information (models, lots, serial numbers)
Lot 007A1037, Ref 010-55-25.
Other devices under the same FDA submission
6 devices cleared under K931665 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 010-55-025Encore Medical, L.P. · Screw, Fixation, Bone4 reports
- DJO SURGICAL 010-55-030Encore Medical, L.P. · Screw, Fixation, Bone2 reports
- DJO SURGICAL 010-55-020Encore Medical, L.P. · Screw, Fixation, Bone1 report
- DJO SURGICAL 010-55-040Encore Medical, L.P. · Screw, Fixation, Bone1 report
- DJO SURGICAL 010-55-045Encore Medical, L.P. · Screw, Fixation, Bone1 report
- DJO SURGICAL 010-55-060Encore Medical, L.P. · Screw, Fixation, Bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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