FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-0085-2008
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; 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
- 479 units.
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
- Lot, serial or model codes
- Lot #: 679631, 678531, 678541, 678551, 678561, 678571, 691661, 692771, 692761, 694351, 694401, 694411, 694421, 698261, 695131, 695911, 697781, 730131, 731451, 731461, 731471, 205452, 736421, 770051, 770061, 770071, 770181, 780151, 783921, 788361, 792671, 794391, 811171, 811181, 811191, 811201, 811291, 832281, 832291, 835521, 842301, 842311, 848671, 854501, 854511, 854981, 874961, 874971, 874981, 882591, 882601, 893581, 893591, 893601, 893611, 903141, 903151, 905561, 925731, 925741, 925751, 927231, 932711, 932721, 933761, 933771, 933781, 944261, 944271, 949411, 949421, 964211, 964221, 964231 and 964241.
- 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