NobelReplace Conical Connection RP 4.3x11.5 mm recall
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Why was NobelReplace Conical Connection RP 4.3x11.5 mm recalled?
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
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?
Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
- Product
- NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- Recalling firm
- Nobel Biocare Usa Llc
- Quantity
- 702 pieces
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
- Recall date
- March 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)