Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure
Integra LifeSciences is recalling 1,053 Mayfield Ultra 360 Base Units because the locking handle mechanism may fail during use, posing a risk to patients.
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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a device used to secure a patient's head during surgery, which presents a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Integra LifeSciences Corporation is recalling 1,053 units of the Mayfield Ultra 360 Base Unit for head positioners. The recall affects Catalogue numbers A2009 and A2029 across various lot numbers. These devices are used to position and hold a patient's head during diagnostic examinations or surgical procedures.
The recall was initiated after an investigation of complaints revealed that the locking handle mechanism of the Base Units has the possibility to fail during use. This failure could compromise the stability of the patient's head position during medical procedures.
The affected units were distributed worldwide, including nationwide in the United States and in numerous foreign countries. Healthcare facilities and government consignees that have these units should stop using them immediately and contact Integra LifeSciences for instructions on how to return or replace the devices.
The recalled product
- Product
- The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be…
- Manufacturer
- Integra LifeSciences Corporation
- Affected units
- 1,053
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 (20)
- All Lot numbers of Mayfield Ultra 360 Base Units
- 73355
- 73356
- 74396
- 74730
- 74398
- 74399
- 75796
- 75816
- 74523
- 75838
- 75859
- 74524
- 75873
- 74890
- 75939
- 74892
- 76420
- 74893
- 74894
Distribution
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