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Flexarm Surgical Holders and Positioners
FLEXBAR MACHINE CORPORATION · Model 99000-R · UDI-DI 00842102114052
10
510(k) clearances
225
Adverse events (1 deaths)
75
Recalls
154
Facilities
Description
Twin FlexArm Plus Laparoscopic System, 10mm Quick Grip Tip, Nathanson Robotic Hook Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-24 | QUANTUM OPS Inc | Due to a manufacturing issue (inadequate weld) for patient head positioning system. |
| 2021-09-13 | Innovative Orthopedic Technologies, LLC | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.