Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
USArtelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Recalling Firm: International Life Sciences
Reason for Recall / Hazard
Augmentation devices failed bacterial endotoxin testing.
Product Description & Identification
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Affected Products
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98399 |
| Address 1 | 8601 Dunwoody Pl Ste 250 |
| Address 2 | N/A |
| Code info | Lot: RK29976/GTIN: 00850003396248 |
| Postal code | 30350-2513 |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | N/A |
| Reason for recall | Augmentation devices failed bacterial endotoxin testing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260206 |
| Initial firm notification | Letter |
| Center classification date | 20260311 |
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Overview
- Recalling FirmInternational Life Sciences
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.
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🚨 SAFETY ALERT: International Life Sciences - Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) Check if your household is affected: https://therecallfile.com/recalls/artelon-flexband-twist-12-ref-tw012-3-85x17mm-hex-anchor-qty-2-5-0x17m/FDA-Z-1556-2026
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