FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 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 number
- Z-1868-2008
- Recalling firm
- Encore Medical, Lp
- 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.
- Status
- Terminated
- Initiated
- 2008-05-08
- Posted
- 2008-08-26
- Terminated
- 2009-09-08
- Reason
- Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 20 units
- Distribution
- Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
- Lot, serial or model codes
- Lots #53876569, Exp 7/23/2013; 53869022, and lot 53873037
- 510(k) numbers
- ["K000817"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28