LCP 236.506Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982160737), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2019Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LO # UNKNOWN, QUANTITY # 9), UNK - GUIDE/COMPRESSION/K-WIRES (PART #: UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN) & UNK - SYNTHES NO FURTHER INFO: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5MM LCP OLECRANON PLATE 6 HOLES/RIGHT/138MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Pain; Skin Erosion

  MAUDE report 8746126 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,