EBI Trochanteric 11mm Long Nail recallZ-0012-06 · Ebi, L.P. · initiated Jun 24, 2005
Terminated All recalls posted in October 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ebi, L.P. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0012-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 24, 2005
- Posted by the FDA
- Oct 7, 2005
- Recalling firm
- Ebi, L.P.
- Quantity
- 102 nails
- Product code
- JDS
- FDA submissions
- K050118
- Distribution
- There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
Product description
EBI Trochanteric 11mm Long Nail.
Code information (models, lots, serial 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.
Other devices under the same FDA submission
13 devices cleared under K050118 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PHOENIX NAIL SYSTEM 14-405080Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- PHOENIX NAIL SYSTEM 14-405065Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- PTN Peritrochanteric Nail 28338Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405024Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405030Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405032Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405034Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405040Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405042Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405050Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405058Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PHOENIX NAIL SYSTEM 14-405070Biomet Orthopedics, LLC · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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