Rebstock Holding Rod for Fixation May Move Uncontrollably
The Rebstock Holding rod for fixation, a surgical instrument, may move or twist uncontrollably during use, potentially compromising patient safety if the movement transfers to attached equipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a device malfunction that could compromise patient safety during surgical procedures. No hospitalizations or injuries reported, so the hazard is potential rather than realized, meeting the rubric criterion for High severity.
Plain-English summary
The FDA is recalling the Rebstock Holding rod for fixation (Art. No. 06-06-285 and 06-06-285MOD), manufactured by Medagent Inc. This surgical instrument is used to hold and fixate flexible Leyla Arms and spatula during medical procedures.
The holding arm may move or twist uncontrollably in the front area. If this uncontrolled movement is transferred to the spatula or other equipment attached to the holding arm, it could lead to serious deterioration of patient safety during surgery.
The recall affects 84 units distributed in Texas and internationally to Algeria, China, Dominican Republic, Germany, India, Japan, Philippines, and the United Kingdom. Affected batches include: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, and 6221673.
Healthcare facilities and medical professionals using this device should discontinue use and contact Medagent Inc for instructions on replacement or corrective action.
The recalled product
- Product
- Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
- Manufacturer
- Medagent Inc
- Affected units
- 84
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Batches: 6221672
- 6222079
- 6230282
- 6230985
- 6230986
- 6231808
- 6222559
- 6231989
- 6221673
Distribution
Distributed in 1 state:
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