5.0 mm Parafix Part Number 22-5011 is a suture anchor metal recallZ-0627-2012 · Innovatech Medical Resources L.P. · initiated Aug 8, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Innovatech Medical Resources L.P. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product is being removed from the field due to an over-label issue.
FDA root cause category: Reprocessing Controls
What the company is doing
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.
Recall details
- Recall number
- Z-0627-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 8, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Innovatech Medical Resources L.P.
- Quantity
- 1 unit
- Product code
- MBI
- FDA submissions
- K042584
- Distribution
- Nationwide Distribution including Texas
Product description
5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair.
Code information (models, lots, serial numbers)
Lot Number 205091
Other devices under the same FDA submission
1 device cleared under K042584 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MAGNUM OM-2500Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 60049).
- Z-0611-2012 · TerminatedOPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
- Z-0614-2012 · TerminatedOPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones
- Z-0628-2012 · TerminatedOPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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