HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable recall: Sterility Concern
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Why was HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- 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: 2013957 2013995 2013996 2016209 2016207 2017775 2017860 2018647 2019852 2019853 2021462 2023240 2023345 2024841 2024742 2026562 2025370 2025438 2027467 2025207 2027434 2027500 2027405 2029350 2029351 2030952 2031022 2031088 2031089 2031156 2033536 2034426 2035500 2034498 2037191 2037151 2039451 2039609 2041070 2042597 2042777 2048390 2048391 2049913 2051216 2049914 2051654 2051655 2051656 2051657 2053912 2053913 2056080 2056081 2056426
- Product
- HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
- 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)