Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed
FDA device recall Z-1868-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
- Date initiated
- 2008-05-08
- Date posted
- 2008-08-26
- Date terminated
- 2009-09-08
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMEGA II MODULAR TOTAL HIP SYSTEM (K000817) | Osteoimplant Technology, Inc. | 2000-06-08 |