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AC DEVICE
Lockdown Medical Ltd · Model LDSS40 · UDI-DI 05060433600302
HTN
Prescription
1
510(k) clearances
1,494
Adverse events (2 deaths)
4
Recalls
265
Facilities
Description
40mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-22 | TriMed Inc. | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to b |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2016-08-12 | Arthrex, Inc. | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. |
| 2013-10-03 | Synthes USA HQ, Inc. | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. |
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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.