Encore Modular Femoral Neck, 12 degree/35 mm recallZ-1868-2008 · Encore Medical, Lp · initiated May 8, 2008
Terminated All recalls posted in August 2008
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
Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form.
Recall details
- Recall number
- Z-1868-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 8, 2008
- Posted by the FDA
- Aug 26, 2008
- Recalling firm
- Encore Medical, Lp
- Quantity
- 20 units
- Product code
- JDI
- FDA submissions
- K000817
- Distribution
- Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
Product description
Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and femoral head orientation in the acetabulum.
Code information (models, lots, serial numbers)
Lots #53876569, Exp 7/23/2013; 53869022, and lot 53873037
Other devices under the same FDA submission
2 devices cleared under K000817 — 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 410-32-108Encore Medical, L.P. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- DJO SURGICAL 410-35-108Encore Medical, L.P. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 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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