25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
FDA Recall Z-0119-2017 · Posted 2016-10-18
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Recalling FirmSynergetics Inc
Recall StatusTerminated
Product CodeHQE
Date Initiated2016-08-11
Date Terminated2017-04-27
Product Quantity72 units
Reason for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Firm Action
A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.
Root Cause
Other
Distribution Pattern
Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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