BIOSTOP recallZ-0951-2023 · Depuy Ireland UC · initiated Dec 19, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Depuy Ireland UC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
On December 19, 2022, the firm notified affected consignees through "Urgent Medical Device Recall" letters. Customers were instructed to immediately identify and quarantine affected product in inventory. Recalled products should not be used. Customers should then contact Sedgwick at [email protected] or call 888-597-5387 to coordinate the return/credits of the subject products.
Recall details
- Recall number
- Z-0951-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2022
- Posted by the FDA
- Jan 12, 2023
- Recalling firm
- Depuy Ireland UC
- Quantity
- 2199 US; 43515 OUS
- Product code
- LZN
- FDA submissions
- K943727
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Latvia, Lebanon, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, and Uruguay.
Product description
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
Code information (models, lots, serial numbers)
Catalog Number Part Description UDI/DI * 546308000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 8 10603295174547 546310000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 10 10603295174554 546312000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12 10603295174561 546314000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14 10603295174578 546316000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16 10603295174585 546318000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18 10603295174592 546320000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20 10603295174608 * UDI-DI on GS1 0603295a0035792 Expiry dates December 2022 thru May 2025 ALL LOTS
Devices named in this recall
7 devices in the FDA device registry whose identifier appears in the recall's code information.
- BIOSTOP 5463-12-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall6 reports
- BIOSTOP 5463-14-000Depuy Orthopaedics, Inc. · Prosthesis, hip, cement restrictor1 recall2 reports
- BIOSTOP 5463-08-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-16-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-18-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-10-000Depuy Orthopaedics, Inc. · Prosthesis, hip, cement restrictor1 recall0 reports
- BIOSTOP 5463-20-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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