ProLite Mesh - mesh, surgical, polymeric recallZ-0712-2018 · Atrium Medical Corporation · initiated Nov 22, 2017
Class II Terminated All recalls posted in February 2018
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 Atrium Medical Corporation 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
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0712-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 22, 2017
- Posted by the FDA
- Feb 23, 2018
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 60 units
- Product code
- FTL
- FDA submissions
- K151437
- Distribution
- Internationally to Spain only.
Product description
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.
Code information (models, lots, serial numbers)
Product Code/REF 1010306-06 Lot Number/LOT: 412298
Other devices under the same FDA submission
46 devices cleared under K151437 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PROLITE 1000306-00Atrium Medical Corporation · Mesh, surgical, polymeric176 reports
- PROLOOP 30902Atrium Medical Corporation · Mesh, surgical, polymeric124 reports
- PROLOOP 30901Atrium Medical Corporation · Mesh, surgical, polymeric94 reports
- PROLITE 1000606-00Atrium Medical Corporation · Mesh, surgical, polymeric86 reports
- PROLOOP 30903Atrium Medical Corporation · Mesh, surgical, polymeric54 reports
- PROLOOP 30900Atrium Medical Corporation · Mesh, surgical, polymeric50 reports
- PROLITE 1001014-00Atrium Medical Corporation · Mesh, surgical, polymeric41 reports
- PROLITE 1010306-02Atrium Medical Corporation · Mesh, surgical, polymeric41 reports
- PROLITE 1000406-00Atrium Medical Corporation · Mesh, surgical, polymeric36 reports
- PROLITE 1000204-00Atrium Medical Corporation · Mesh, surgical, polymeric33 reports
- PROLITE 1010306-06Atrium Medical Corporation · Mesh, surgical, polymeric18 reports
- PROLITE ULTRA 30715Atrium Medical Corporation · Mesh, surgical, polymeric16 reports
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 18, 2026. Text above is shown as published by the FDA.
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