Recall Z-1317-2020
Nobel Biocare Usa Llc · initiated March 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - 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.
Codes / lots: (01)07332747083774(10)73303 Catalog# 37472 & Tri-Chi
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.
FDA-determined cause: Packaging process control
Action taken
On 3/27/2018 the firm issued a recall notice by email to affected consignees. The recall notification informed the following actions to be taken by the consignees: 1. Identify affected devices as detailed in the Customer Reply Form. 2. Do not use affected devices. 3. Send back the Customer Reply Form and the affected devices. The firm will replace affected devices free of charge. This letter needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We kindly ask you to follow instructions provided in this Recall Letter and return the attached Customer Reply Form to the firm via email or fax at 714- 282-5073.
Details
- Recall number
- Z-1317-2020
- Initiated
- March 14, 2019
- Posted by FDA
- February 19, 2020
- Terminated
- February 15, 2024
- Product code
- NDP – Accessories, Implant, Dental, Endosseous
- Quantity
- 197 units
- 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.
- Recalling firm
- Nobel Biocare Usa Llc, Yorba Linda, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1302-2020 Class II | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1303-2020 Class II | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1304-2020 Class II | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1305-2020 Class II | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1306-2020 Class II | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1307-2020 Class II | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1308-2020 Class II | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1309-2020 Class II | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1310-2020 Class II | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1311-2020 Class II | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1312-2020 Class II | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1313-2020 Class II | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1314-2020 Class II | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1315-2020 Class II | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1316-2020 Class II | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1318-2020 Class II | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1319-2020 Class II | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1320-2020 Class II | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1321-2020 Class II | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1322-2020 Class II | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1323-2020 Class II | Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1324-2020 Class II | Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |
| Z-1325-2020 Class II | Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for…Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be… | 03/14/2019Terminated |