6.5mm Cancellous Bone Screw recallZ-0139-2013 · Encore Medical, Lp · initiated Sep 28, 2012
Class II Terminated All recalls posted in October 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
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
FDA root cause category: Labeling mix-ups
What the company is doing
Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255
Recall details
- Recall number
- Z-0139-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 28, 2012
- Posted by the FDA
- Oct 25, 2012
- Recalling firm
- Encore Medical, Lp
- Quantity
- 1 unit
- Product code
- HWC
- FDA submissions
- K931665
- Distribution
- Nationwide Distribution only to CA.
Product description
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Code information (models, lots, serial numbers)
Model Number 10-55-025, Lot Number 006A1057.
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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