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.
FDA Recall Z-1868-2008 · Posted 2008-08-26
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJDI
Date Initiated2008-05-08
Date Terminated2009-09-08
Product Quantity20 units
Reason for Recall
Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
Firm Action
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
Distribution Pattern
Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.