FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-0087-2008
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- Status
- Terminated
- Initiated
- 2007-08-02
- Posted
- 2007-11-07
- Terminated
- 2008-01-09
- Reason
- Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Root cause
- Packaging change control
- Action
- Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
- Quantity
- 632 units.
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
- Lot, serial or model codes
- Lot #: 629071, 677121, 677131, 678651, 678661, 678671, 678681, 679641, 691251, 691261, 691271, 693871, 693881, 694511, 694521, 694531, 695111, 697791, 698971, 698981, 730201, 731491, 733951, 734531, 736471, 736481, 736761, 738091, 738101, 738901, 770091, 772351, 772361, 777411, 780171, 783941, 788411, 788421, 795501, 795511, 812221, 813521, 813531, 814301, 814311, 817571, 834021, 834031, 835551, 836171, 842341, 842351, 845961, 847381, 854351, 854421, 854431, 854441, 855871, 855881, 857721, 875011, 875021, 878341, 878361, 878551, 878561, 891291, 891311, 893621, 894391, 894401, 905591, 905601, 907061, 907071, 925781, 925791, 932751, 938231, 938241, 938251, 949451, 949461, 951091, 959761, 959771, 964321, 964331, 964341 and 964351.
- 510(k) numbers
- ["K953510"]
- PMA numbers
- not on file
- Product code
- KWY
- 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