EBI Trochanteric 11mm Long Nail.
FDA Recall Z-0012-06 · Posted 2005-10-07
Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeJDS
Date Initiated2005-06-24
Date Terminated2006-07-03
Product Quantity102 nails
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.
Firm 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.
Root Cause
Other
Distribution Pattern
There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.