Z-1556-2026Class II

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm...

Name: Z-1556-2026 Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm...
Creator: International Life Sciences
Published: 2026-02-06
License: https://open.fda.gov/license/

International Life Sciences / initiated 2026-02-06 / Open, Classified / root cause: manufacturing process

FDA source

International Life Sciences began a recall of Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) on 2026-02-06. FDA classified it as Class II and gives the reason as "Augmentation devices failed bacterial endotoxin testing". 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-1556-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-06
Posted: 2026-03-11
Recalling firm: International Life Sciences
Product: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Product code: OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Reason for recall: Augmentation devices failed bacterial endotoxin testing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 6, 2026, International Life Science ( subsidiary of Stryker) issued a Urgent: Medical Device Recall notification to affected consignees. International Life Science asked consignees to take the following actions: 1. Immediately check your internal inventory to locate the product, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Review the product issue and risks as communicated and communicate the issue as appropriate in your organization. 3. Return the enclosed business reply form by email a. Response is required, even if you may not have any physical inventory on site anymore. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s). 5. Maintain awareness of this communication internally until required actions have been completed within your facility. 6. If you have further distributed the affected product, please notify the applicable parties. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details, so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers.
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Product codes and lots: Lot: RK29976/GTIN: 00850003396248

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1556-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1554-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-11
Z-1555-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-11
Z-1556-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-11

Product code OWW

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)