FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-1065-2007
- Recalling firm
- Encore Medical, Lp
- Product
- ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
- Status
- Terminated
- Initiated
- 2007-04-12
- Posted
- 2007-07-23
- Terminated
- 2007-07-25
- Reason
- Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
- Root cause
- Other
- Action
- Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
- Quantity
- 2 units.
- Distribution
- Product distributed to surgical centers in CT, KS and MO.
- Lot, serial or model codes
- Lot #Y131E and 2475.
- 510(k) numbers
- ["K000817"]
- PMA numbers
- not on file
- Product code
- JDI
- 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