RECLAIM 1976-14-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295077008), received between Feb 28, 2019 and Sep 19, 2019 — classified as 1 injury, 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K102080); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Fracture; Off-Label Use; Fracture; Off-Label Use

  IT WAS REPORTED THAT DURING PROXIMAL REAMING WITH STEM IMPLANT IN PLACE, THE REAMER PLUNGED INTO THE IMPLANT DAMAGING THE TAPER AND SURGEON HAD TO UPSIZE STEM. WHICH ALSO CAUSED THE PROXIMAL BODY TO BE WASTED BECAUSE NEXT SIZE IMPLANT SAT UP HIGHER. DOE: (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088025 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION. DOI: (B)(6) 2014 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8378798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102080. One submission often covers many models, so check the product and lot details in each record.

• Z-2082-2014 · Jun 3, 2014 · Terminated
  RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during
• Z-2083-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking ta
• Z-2084-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf