EARP INSTRUMENTS
NVision Biomedical Technologies, Inc. · Model EARP-T-2235-1212 · UDI-DI 00810135960892
Description
EARP, TRIAL 22X35X12 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-01-31 | Technicality Inc. | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-08 | ENDO Pharmaceuticals Solutions, Inc. | No expiration dates printed on the packaging |
| 2022-11-02 | Arthrex, Inc. | The devices may be packaged with the wrong reamer size. |
| 2021-12-22 | FlexDex Inc. | The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in th |
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