FDAClass IIOctober 28, 2020

RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable recall: Sterility Concern

RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805

Why was RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-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: 2025354 2031116 2040066 2040702 2042557 2049638 2053749 2055239

Product
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
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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