FDAClass IIOctober 28, 2020

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable recall: Sterility Concern

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290

Why was OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- 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: 2012935 2013910 2016229 2017812 2018635 2019990 2021454 2022268 2024711 2025147 2027400 2029394 2030945 2037184 2038460 2038795 2039253 2039444 2045859 2045858 2045860 2045861 2048368 2049884 2048367

Product
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)
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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