FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-0091-2008
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; 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
- 304 units.
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
- Lot, serial or model codes
- Lot #: 624391, 675921, 678791, 678801, 678811, 678821, 679691, 691671, 693931, 693941, 695061, 695921, 696971, 697101, 699941, 208562, 208582, 732861, 733821, 733841, 734401, 735741, 736541, 770141, 773291, 773301, 777461, 779901, 783971, 788521, 794431, 797061, 830311, 831511, 835591, 835601, 842411, 842421, 857791, 872071, 882641, 892391, 892401, 905891, 905901, 907231, 933871, 938271, 958951, 964411, 964421 and 421531A.
- 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