RECLAIM 1977-21-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295077312), received between Jun 10, 2019 and Jun 26, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryJun 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A 20 TO 30-MINUTE SURGICAL DELAY IN ATTEMPTING TO SEPARATE THE BODY WHICH WAS UNSUCCESSFULLY DONE. NO REPORTS OF PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 19614889 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND SURGEON REMOVED ALL COMPONENTS. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8683922 ↗

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-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
• 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