Z-0157-2021Class II

TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608

Name: Z-0157-2021 TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
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 TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608 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-0157-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-09
Posted: 2020-10-21
Recalling firm: Smith & Nephew, Inc.
Product: TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
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: 2012718

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0157-2021
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)