Z-0712-2018Class II

ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies...

Name: Z-0712-2018 ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies...
Creator: Atrium Medical Corporation
Published: 2017-11-22
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2017-11-22 / Terminated / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and... on 2017-11-22. FDA classified it as Class II and gives the reason as "An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0712-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-22
Posted: 2018-02-23
Terminated: 2018-07-30
Recalling firm: Atrium Medical Corporation
Product: ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Please examine inventory to determine if you have any of the affected products listed on page 1. If so, please remove affected products, quarantine them, and place in a secure location. If you have affected product, please contact Getinge Customer Service at [email protected] for a Return Authorization (RA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents, and using the shipping instructions provided, arrange for pick up with the designated delivery service provider. Please complete and sign the enclosed Urgent Medical Device Field Safety Notice to acknowledge receipt. Return the completed form to the following e-mail address: [email protected] For further questions, please call (973) 709-7654.
Quantity in commerce: 60 units
Distribution: Internationally to Spain only.
Product codes and lots: Product Code/REF 1010306-06 Lot Number/LOT: 412298

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0712-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0712-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code FTL

K151437Class IIProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugAtrium Medical Corporation / cleared 2015-08-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)