HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable recall: Sterility Concern
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Why was HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- 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: 2013923 2013951 2013987 2016163 2017827 2017828 2018645 2018644 2018753 2020065 2021559 2024738 2024839 2025433 2025435 2025436 2025367 2027468 2027435 2027501 2029263 2029398 2031090 2031091 2034427 2034428 2035537 2035538 2035539 2036725 2041201 2041202 2045870 2045869 2048392 2048394 2048395 2049915 2049916 2052172 2052173 2052174 2052175 2052177 2048393 2056427 2056428
- Product
- HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
- 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)