Z-0928-06

Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of...

Name: Z-0928-06 Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of...
Creator: Plus Orthopedics USA
Published: 2006-02-22
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2006-02-22 / Terminated

FDA source

Plus Orthopedics USA began a recall of Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp... on 2006-02-22. The reason FDA records is "PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0928-06
Status: Terminated
Initiated: 2006-02-22
Posted: 2006-06-02
Terminated: 2007-12-13
Recalling firm: Plus Orthopedics
Product: Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
FDA root cause: Other
Action: There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.
Quantity in commerce: 5
Distribution: There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York.
Product codes and lots: Revision A Serial Number: None

Product code KTT

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)