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A.L.P.S.ANATOMIC FIBULA LOCKING PLATE

Biomet Orthopedics, LLC · Model 8562-06-010 · UDI-DI 00887868061981

HTN JDW HSB HRS KTT HTY LXT HWC Prescription

510(k) clearances

1,494

Adverse events (2 deaths)

Recalls

265

Facilities

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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Data 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.