Home › Embody, Inc. › Dual Anchor Inserter with Bioabsorbable Anchors
Dual Anchor Inserter with Bioabsorbable Anchors
Embody, Inc. · Model TR-0001-21 · UDI-DI 00810063820152
MAI
Prescription
1
510(k) clearances
17,071
Adverse events
97
Recalls
149
Facilities
Description
The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone dyed with D&C Violet No. 2. Two each of the Bioabsorbable Anchors are provided sterile for single-use only and are packaged preloaded in a single anchor inserter instrument, the Dual Anchor Inserter, in a dual sterile pouch configuration.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | ConMed Corporation | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2023-04-13 | DePuy Mitek, Inc., a Johnson & Johnson Co. | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be r |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.