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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
Lots #53876569, Exp 7/23/2013, 53869022, and lot 53873037
Products Sold
Lots #53876569, Exp 7/23/2013; 53869022, and lot 53873037
A medical device manufacturer is recalling Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin due to Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IN, KS, SD, WA
Page updated: Jan 10, 2026