EBI Trochanteric 11mm Long Nail. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EBI Trochanteric 11mm Long Nail.
Lot Codes / Batch Numbers
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.
Products Sold
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.
A medical device manufacturer is recalling EBI Trochanteric 11mm Long Nail. due to Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026