Z-0367-2010

Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet...

Name: Z-0367-2010 Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet...
Creator: Biomet, Inc.
Published: 2009-08-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-08-06 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534... on 2009-08-06. The reason FDA records is "Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches". 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-0367-2010
Status: Terminated
Initiated: 2009-08-06
Posted: 2009-11-19
Terminated: 2010-10-06
Recalling firm: Zimmer GmbH
Product: Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "Urgent Medical Device Recall Notice" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the "FAX back Response Form" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics. Direct questions related to the recall notification by calling at 1-800-348- 9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM.
Quantity in commerce: 19
Distribution: United States (Florida and Pennsylvania).
Product codes and lots: Lot Number 087190.

Product code FZX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)