Z-0951-2023Class II

BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000...

Name: Z-0951-2023 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000...
Creator: Depuy Ireland UC
Published: 2022-12-19
License: https://open.fda.gov/license/

Depuy Ireland UC / initiated 2022-12-19 / Open, Classified / root cause: manufacturing process

FDA source

Depuy Ireland UC began a recall of BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size... on 2022-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0951-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-19
Posted: 2023-01-12
Recalling firm: Depuy Ireland UC
Product: 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)
Product code: LZN Cement Obturator
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2199 US; 43515 OUS
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0951-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0951-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-12

Product code LZN

K943727Class IIBiostop G Bone Cement RestrictorLandos, Inc. / cleared 1995-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)