FDA Medical Device Recalls (openFDA)
EBI, L.P.: EBI Trochanteric 11mm Long Nail.
- Recall number
- Z-0012-06
- Recalling firm
- EBI, L.P.
- Product
- EBI Trochanteric 11mm Long Nail.
- Status
- Terminated
- Initiated
- 2005-06-24
- Posted
- 2005-10-07
- Terminated
- 2006-07-03
- Reason
- Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.
- Root cause
- Other
- Action
- The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005.
- Quantity
- 102 nails
- Distribution
- There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
- Lot, serial or model codes
- Catalog No./Lot Nos: 28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589; 28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614; 28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540; 28348/164545.
- 510(k) numbers
- ["K050118"]
- PMA numbers
- not on file
- Product code
- JDS
- Firm FEI
- 2242816
- Firm city
- Parsippany
- Firm state
- NJ
- 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