FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-0086-2008
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; 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
- 776 units.
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
- Lot, serial or model codes
- Lot #: 640791, 640801, 640811, 677101, 677111, 678581, 678591, 678601, 678611, 678621, 679611, 679621, 693841, 693851, 693861, 695121, 695861, 697851, 697861, 698771, 730141, 730221, 731481, 003612, 003622, 003632, 003642, 208672, 735781, 736431, 736441, 736451, 736461, 736751, 737391, 738431, 738891, 738911, 770081, 770191, 772371, 776721, 778421, 780161, 783931, 788381, 788391, 794401, 795481, 795491, 812181, 812191, 812201, 812211, 813511, 817551, 817561, 833181, 833191, 834981, 834991, 837691, 837791, 842321, 842331, 847351, 847361, 847391, 847401, 854341, 854381, 854391, 854401, 854411, 857691, 857701, 874991, 875001, 878331, 878351, 878531, 878541, 882611, 882621, 882631, 891271, 891281, 891301, 893631, 893641, 905571, 905581, 907081, 907091, 907101, 907111, 925761, 925771, 932731, 932741, 938211, 938221, 949431, 949441, 951081, 964251, 964261, 964271, 964281, 964291, 964301, 964311 and 421494A.
- 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