Reported Mar 2, 2022 · Terminated
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Nobel Biocare USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nobel Biocare Usa Llc · 22715 Savi Ranch Pkwy · Yorba Linda, CA · 92887-4609
Is this the product you have?
- NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 3670707332747160529UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618 — 07332747160529(01)07332747160529(10)13116496(11)210720(17)260618 — 07332747160529(01)07332747160529(10)13116497(11)210720(17)260618 — Lot Numbers: 13116495, 13116496, 13116497 - Amount recalled
- 702 pieces
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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