Z-2012-2008

Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix...

Name: Z-2012-2008 Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix...
Creator: Ebi, L.p.
Published: 2008-05-07
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2008-05-07 / Terminated / root cause: manufacturing process

FDA source

EBI, L.P. began a recall of Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to... on 2008-05-07. The reason FDA records is "Customer complaint received regarding the separation of the mallet handle during a medical procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2012-2008
Status: Terminated
Initiated: 2008-05-07
Posted: 2008-09-16
Terminated: 2008-10-22
Recalling firm: Ebi, LLC
Product: Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis.
Product code: FZY Hammer, Surgical
Reason for recall: Customer complaint received regarding the separation of the mallet handle during a medical procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall letters were sent to Sales reps and distributors on May 7, 2007. Questions should be directed to William Hennig, QA Manager at 973-299-9300.
Quantity in commerce: 38 mallets
Distribution: Product was distributed to 20 Biomet sales representatives and distributors nationwide.
Product codes and lots: Lot numbers 502398, 503684; Catalog number: 14-442053-00

Product code FZY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)