FDA Device recall Z-0167-2021
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
- FDA Device
- Class II
- ongoing
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697 by Smith And Nephew, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0167-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-09 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
Reason
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
Identifiers
| code_info | Batch Numbers: 2013959 2016246 2017861 2018756 2019936 2021510 2023286 2024791 2025371 2027465 2027498 2027…Batch Numbers: 2013959 2016246 2017861 2018756 2019936 2021510 2023286 2024791 2025371 2027465 2027498 2027403 2029347 2031019 2031087 2031153 2033535 2035497 2035534 2037188 2037148 2038325 2039607 2041068 2042774 2044894 2046452 2048384 2048385 2049906 2051015 2051016 2052167 2052166 2056074 2056423 2056424 2057383 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0167-2021%22
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