BIOSTOP 5463-14-000Recalls & reported problems
Depuy Orthopaedics, Inc. · BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14 · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295174578), received between Feb 14, 2018 and Jul 12, 2019 — classified as 2 malfunctions.
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
- Connection Problem1
- Difficult to Remove1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2019Fracture; Difficult to Remove; Connection Problem; Fracture; Difficult to Remove; Connection Problem
AT THE MOMENT OF THE PLACEMENT OF BIOSTOP PLUG NUMBER 12 AFTER HAVING CORRECTLY PREPARED THE MEDULLARY CANAL, THE SURGEON INTRODUCES THE CAP WITH THE CORRESPONDING SETTER. IT IS CAUGHT IN THE CANAL, BUT IN AN ATTEMPT BY THE SURGEON TO REMOVE THE PLUG FROM THE CAP, IT DECAPITATED. WHEN THIS SITUATION OCCURRED, ANOTHER BIOSTOP NUMBER 14 PLUG WAS OPENED, SINCE THE PREVIOUS ONE HAD BROKEN, BUT WHEN PLACING THIS NEW IMPLANT, THE SAME ISSUE HAPPENED. SURGERY: RTC HYBRID, PINNACLE / C-STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8785819 ↗MalfunctionFeb 14, 2018Break; Break
OCCURRENCE: CEMENT RESTRICTOR BREAKING AT THE TIME OF USE. DETAILS: ON (B)(6) 2018, IN THE TOTAL HIP ARTHROPLASTY SURGERY, USING THE 14 MM BIO CEMENT RESTRICTOR, IT WAS BROKEN. ACCORDING TO REPORTS THIS IS NOT THE FIRST TIME THIS HAPPENS. FOR THIS NEW EVENT, HE CALLED ATTENTION TO RECORD WHAT HAPPENED. IT WAS IDENTIFIED THAT THE INSTRUMENTS USED TODAY IN THE C-STEM AMT STEM BOX, "IS NOT COMPATIBLE WITH THE PLUG (CEMENT RESTRICTOR)". WE REQUEST CLARIFICATION AS TO THE INSTRUMENTS AND TECHNIQUES OF USE SO THAT THE PROBLEM DOES NOT HAPPEN AGAIN. PRODUCT AVAILABLE FOR ANALYSIS. PRODUCT INFORMATION: (B)(4) AND LOT: 16F1306005.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7269835 ↗
Other Prosthesis, hip, cement restrictor devices
- BIOSTOP 5463-10-000Depuy Orthopaedics, Inc. · Prosthesis, hip, cement restrictor1 recall0 reports
- BioPrep 0206710000Stryker Corporation · Prosthesis, hip, cement restrictor11 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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