Spectra System/Legacy Guided Surgery Handle Kit recall
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows…
Why was Spectra System/Legacy Guided Surgery Handle Kit recalled?
The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293
- Product
- Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 560 units (worldwide)
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.
- Recall date
- December 27, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)