FDA Device recall Z-0173-2021
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
- FDA Device
- Class II
- ongoing
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801 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-0173-2021 |
| 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 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
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: 2013918 2016156 2017774 2018804 2021456 2023227 2024815 2025049 2027438 2029400 2029401 2033…Batch Numbers: 2013918 2016156 2017774 2018804 2021456 2023227 2024815 2025049 2027438 2029400 2029401 2033291 2033290 2034431 2034432 2034499 2034500 2034501 2034502 2035698 2037194 2039456 2045894 2048429 2048430 2051045 2051046 2049950 2049951 2053927 2056086 2056434 |
|---|
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-0173-2021%22
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