FDAClass IIFebruary 26, 2020

Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm recall

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.…

Why was Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm recalled?

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.

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?

(01)07332747083767(10)73491 (01)07332747083767(10)73600 (01)07332747083767(10)73296 (01)07332747083767(10)73315 (01)07332747083767(10)73595 Catalog# 37471

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.…
Recalling firm
Nobel Biocare Usa Llc
Quantity
2470 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.
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls