FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.
- Recall number
- Z-0799-06
- Recalling firm
- Encore Medical, Lp
- Product
- Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.
- Status
- Terminated
- Initiated
- 2006-01-12
- Posted
- 2006-04-27
- Terminated
- 2006-07-11
- Reason
- Voids in the porous coating of a component used in total hip replacement surgery.
- Root cause
- Other
- Action
- Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians.
- Quantity
- Total of 30 units
- Distribution
- Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada
- Lot, serial or model codes
- Lot numbers 276202 and 270512
- 510(k) numbers
- ["K950542"]
- PMA numbers
- not on file
- Product code
- LPH
- 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