HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable recall: Sterility Concern
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
Why was HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- 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: 2014002 2016196 2017814 2020051 2021388 2023272 2024724 2026266 2024759 2025289 2027469 2030955 2031023 2033400 2035501 2036291 2038328 2039263 2048404 2049924 2051020 2053921 2056432 2057402
- Product
- HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
- 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)