Z-0170-2021Class II

HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706

Name: Z-0170-2021 HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Creator: Smith & Nephew, Inc.
Published: 2020-09-09
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-09-09 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706 on 2020-09-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0170-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-09
Posted: 2020-10-21
Recalling firm: Smith & Nephew, Inc.
Product: HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Smith & Nephew issued Urgent Medical Device Recall letter (R-2020-19) FSN on September 9, 2020 via email or overnight mail to customers that received affected products. Letter states reason for recall, health risk, and action to take: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected]. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0136-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0137-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0138-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0139-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0140-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0141-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0142-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0143-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0144-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0145-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0146-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0147-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0148-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0149-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0150-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0151-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0152-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0153-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0154-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0155-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0156-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0157-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0158-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0159-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0160-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0161-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0162-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0163-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0164-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0165-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0166-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0167-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0168-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0169-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0170-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0171-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0172-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0173-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0174-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21
Z-0175-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-21

Product code MAI

K151105Class IISmith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra FaSmith & Nephew, Inc. / cleared 2015-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)