Z-1806-2010

Calcium Sulfate Hemihydrate 1.0 gram kits

Name: Z-1806-2010 Calcium Sulfate Hemihydrate 1.0 gram kits
Creator: Ace Surgical Supply Co., Inc.
Published: 2010-05-14
License: https://open.fda.gov/license/

Ace Surgical Supply Co., Inc. / initiated 2010-05-14 / Terminated / root cause: manufacturing process

FDA source

Ace Surgical Supply Co., Inc. began a recall of Calcium Sulfate Hemihydrate 1.0 gram kits on 2010-05-14. The reason FDA records is "Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1806-2010
Status: Terminated
Initiated: 2010-05-14
Posted: 2010-06-16
Terminated: 2012-02-02
Recalling firm: Ace Surgical Supply Co., Inc.
Product: Calcium Sulfate Hemihydrate 1.0 gram kits.
Product code: LYC Bone Grafting Material, Synthetic
Reason for recall: Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits. Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.
Quantity in commerce: 7930
Distribution: Class 2 recall - Worldwide distribution . Item Number 505-2001: South Africa, Australia, Vietnam, Ontario, Canada, Italy, Lebanon, Petaling Jaya, Malaysia, Portugal, and West Indies. Item Number 505-2002: Australia, Bermuda, Canada, Lebanon, Petaling Jaya, Malaysia, and Portugal.
Product codes and lots: Calcium Sulfate Hemihydrate 1.0 gram Product Code #5052001 lot numbers: 08030106, 08030030, 08040035, 08050025, 08070036, 08090049, 08100092, 08110041, 08120097, 09010055, 09020041, 09030047, 09040017, 09050004, 09060013, 09060095, 09070046, 09080033, 09090026, 09100002, 09100066, 09120011, 09120070, 10010007, 10010067, 10020064, 10030003, 10030060, 10040011, 10040046

Product code LYC

K051381Class IIAce Surgicalplaster Calcium Sulface HemihydrateAce Surgical Supply Co., Inc. / cleared 2005-07-15

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)