Z-0614-2012

OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft...

Name: Z-0614-2012 OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft...
Creator: Innovatech Medical Resources L.P.
Published: 2011-08-08
License: https://open.fda.gov/license/

Innovatech Medical Resources L.P. / initiated 2011-08-08 / Terminated / root cause: labeling and UDI

FDA source

Innovatech Medical Resources L.P. began a recall of OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones on 2011-08-08. The reason FDA records is "Product is being removed from the field due to an over-label issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0614-2012
Status: Terminated
Initiated: 2011-08-08
Posted: 2012-01-11
Terminated: 2012-09-27
Recalling firm: Innovatech Medical Resources L.P.
Product: OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Product is being removed from the field due to an over-label issue.
Root cause tag: labeling and UDI
FDA root cause: Reprocessing Controls
Action: Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066.
Quantity in commerce: 7 Units
Distribution: Nationwide Distribution including Texas
Product codes and lots: Lot Number 1004579

Product code MBI

K101448Class IIOpus Speedscrew SystemArthrocare Corp. / cleared 2010-06-21

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)