FDA Medical Device Recalls (openFDA)
Innovatech Medical Resources L.P.: OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
- Recall number
- Z-0628-2012
- Recalling firm
- Innovatech Medical Resources L.P.
- Product
- OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
- Status
- Terminated
- Initiated
- 2011-08-08
- Posted
- 2012-01-11
- Terminated
- 2012-09-27
- Reason
- Product is being removed from the field due to an over-label issue.
- 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
- Lot Number (QTY): 110730 (7 units), 110874 (2 units), 110400 (7 units), 119256 (1 unit) and 117489 (1 unit)
- Distribution
- Nationwide Distribution including Texas
- Lot, serial or model codes
- Lot Numbers 110730, 110874, 110400, 119256 and 117489
- 510(k) numbers
- ["K042584"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009124511
- Firm city
- Midlothian
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28