Z-0012-06

EBI Trochanteric 11mm Long Nail

Name: Z-0012-06 EBI Trochanteric 11mm Long Nail
Creator: Ebi, L.p.
Published: 2005-06-24
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2005-06-24 / Terminated / root cause: design

FDA source

EBI, L.P. began a recall of EBI Trochanteric 11mm Long Nail on 2005-06-24. The reason FDA records is "Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0012-06
Status: Terminated
Initiated: 2005-06-24
Posted: 2005-10-07
Terminated: 2006-07-03
Recalling firm: Ebi, LLC
Product: EBI Trochanteric 11mm Long Nail.
Product code: JDS Nail, Fixation, Bone
Reason for recall: 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 tag: design
FDA 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 in commerce: 102 nails
Distribution: There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
Product codes and lots: 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.

Product code JDS

K050118Class IIEbi Trochanteric Nail SystemEbi, L.P. / cleared 2005-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)