Recall Z-1555-2026 ยท OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
International Life Sciences
Artelon FlexBand Plus Ref: 41054 & 41057
| Date | Mar 11, 2026 (initiated Feb 6, 2026) |
| Status | Open, Classified |
| Reason | Augmentation devices failed bacterial endotoxin testing. |
| 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 m |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230316 | FlexBand; FlexPatch; FlexBand Plus International Life Sciences, May 26, 2023 |