Recall Z-1295-2013
Integra LifeSciences Corporation · initiated March 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
Codes / lots: 1104622, 1104962 1110241, 1110242 1110264, 1110783
Reason for recall
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
FDA-determined cause: Process control
Action taken
The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: FCA@integralife.com or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.
Details
- Recall number
- Z-1295-2013
- Initiated
- March 28, 2013
- Posted by FDA
- May 10, 2013
- Terminated
- June 3, 2015
- Product code
- LPG – Material, Dressing, Surgical, Polylactic Acid
- Quantity
- 42,570 boxes
- Distribution
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- Recalling firm
- Integra LifeSciences Corporation, Plainsboro, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1282-2013 Class II | Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1283-2013 Class II | Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1284-2013 Class II | DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1285-2013 Class II | DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1286-2013 Class II | NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1287-2013 Class II | NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1288-2013 Class II | INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1289-2013 Class II | Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1290-2013 Class II | Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1291-2013 Class II | Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1292-2013 Class II | CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1293-2013 Class II | CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1294-2013 Class II | HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1296-2013 Class II | OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1297-2013 Class II | Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1298-2013 Class II | OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1299-2013 Class II | BioMend Extend" Absorbable Collagen Membrane BioMend Extend" Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1300-2013 Class II | Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1301-2013 Class II | BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |
| Z-1302-2013 Class II | Absorbable Collagen Sponge Provided As Intermediate to Another CompanyDue to the process deviation, product lots in question may have been released with higher levels of pyrogens… | 03/28/2013Terminated |