FDAClass IIOctober 28, 2020

OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable recall: Sterility Concern

OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996

Why was OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable recalled?

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Batch Numbers: 2012912 2017844 2019840 2021496 2024714 2033500 2049663 2052725 2055727

Product
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A
Distribution
Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA
Recall date
October 28, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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