# FDA recall Z-1316-2020

> **Nobel Biocare Usa Llc** · Class II · device recall initiated 2019-03-14.

## Product

Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.

## Reason for recall

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

## Distribution

Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

## Key facts

- **Recall number:** Z-1316-2020
- **Recalling firm:** Nobel Biocare Usa Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-14
- **Report date:** 2020-02-26
- **Termination date:** 2024-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yorba Linda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2020

## Citation

> AI Analytics. FDA recall Z-1316-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1316-2020. Source: US FDA. Licensed CC0.

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