NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Reported: March 2, 2022 Initiated: December 17, 2021 #Z-0658-2022
Product Description
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Reason for Recall
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.
Details
- Recalling Firm
- Nobel Biocare Usa Llc
- Units Affected
- 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.
- Location
- Yorba Linda, CA
Frequently Asked Questions
What product was recalled? ▼
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R. Recalled by Nobel Biocare Usa Llc. Units affected: 702 pieces.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2022. Severity: Moderate. Recall number: Z-0658-2022.
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