Genesis knotless anchors recalled after reports of device failure
Aju Pharm is recalling 1,163 units of the Genesis Knotless Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record cites reported device failures including anchor breakage and pull out, with no injuries reported.
Plain-English summary
The Genesis Knotless Anchor is being recalled by Aju Pharm Co., Ltd.
The reason given in the enforcement record is reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage and secondary packaging breakage.
The record lists 1,163 units under model numbers 10KPN4751 and 10KPN5501, all UDI codes and all lots. The record gives distribution as US nationwide in the states of California and Puerto Rico. The FDA has classified the action as Class II.
The record describes failures of the device itself and reports no injuries. Facilities should quarantine affected stock and follow Aju Pharm's instructions.
The recalled product
- Product
- Goldenroot Lemon Ginger Hibiscus Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32821 4. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
- Manufacturer
- Weaver's Brew LLC
- Category
- Medical Device — Suture anchor
- Affected units
- 1,014
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Use By Dates up to 6/14/26.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Weaver's Brew LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Weaver's Brew LLC
See all →- HighYuzu ginger lemongrass beer recalled over possibly unpasteurized ginger juice
FDA (Food) · 2026-02-04
- HighLemon ginger elderberry beer recalled over possibly unpasteurized ginger juice
FDA (Food) · 2026-02-04
- HighGinger beer recalled over ginger juice that may be unpasteurized
FDA (Food) · 2026-02-04
- ModerateNerve block trays recalled over cracking MASTISOL adhesive tubing inside
FDA (Food) · 2026-02-04
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12