BIOSTOP 5463-16-000Recalls & reported problems
Depuy Orthopaedics, Inc. · BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16 · Class 2 · Implant
All models of BIOSTOP (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295174585), received between Jul 16, 2019 and Jul 16, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 19, 2022Class IIOpen, Classified
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
Z-0951-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2019Break; Break
BIOSTOP WAS OPENED AND IT BROKE WHEN PLACED ON THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8792942 ↗
Other CEMENT OBTURATOR devices
- BIOSTOP 5463-12-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall6 reports
- BIOSTOP 5463-08-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-18-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-20-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall0 reports
- NA 0306703000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- ACM BioPrep 0306705000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- PREP-IM 121010Smith & Nephew, Inc. · CEMENT OBTURATOR10 reports
- CEMENT RESTRICTOR EBO102Tornier · CEMENT OBTURATOR8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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