Z-1692-2017Class II

UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use...

Name: Z-1692-2017 UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use...
Creator: United Orthopedic Corporation
Published: 2017-02-10
License: https://open.fda.gov/license/

United Orthopedic Corp. / initiated 2017-02-10 / Terminated / root cause: design

FDA source

United Orthopedic Corporation began a recall of UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and... on 2017-02-10. FDA classified it as Class II and gives the reason as "The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1692-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-10
Posted: 2017-03-01
Terminated: 2017-06-28
Recalling firm: United Orthopedic Corp.
Product: UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Root cause tag: design
FDA root cause: Device Design
Action: United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366.
Quantity in commerce: 33 units
Distribution: Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Product codes and lots: Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-29

Product code LXH

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)