Spectra-System/Legacy Guided Surgery Handle Kit recall
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a…
Why was Spectra-System/Legacy Guided Surgery Handle Kit recalled?
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
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 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
- Product
- Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 84 units
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.
- Recall date
- September 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)