FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-0088-2008
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; 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
- 605 units.
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
- Lot, serial or model codes
- Lot #: 644031, 672331, 677061, 677981, 677991, 678691, 678701, 678711, 678721, 679651, 679661, 697671, 691281, 691291, 693261, 699171, 730241, 735791, 736491, 736501, 736511, 736771, 737811, 738441, 738451, 738461, 770101, 770111, 770221, 773281, 777421, 778431, 782551, 788441, 788451, 810911, 811211, 813501, 830751, 830761, 830911, 830921, 835531, 835541, 842361, 842371, 847411, 848681, 848691, 853541, 857731, 857741, 857751, 875571, 875581, 878371, 878381, 878391, 885381, 885401, 892331, 894241, 894251, 905611, 907121, 907131, 907141, 907211, 925801, 925811, 927241, 927251, 927261, 932761, 949471, 949491, 949851, 951101, 951111, 951121, 958941, 966131, 966141 and 982721.
- 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