ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia r
FDA device recall Z-0712-2018 · posted 2018-02-23 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- 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.
- Action taken
- 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 internationalcs@atriummed.com 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: MESH2017@getinge.com For further questions, please call (973) 709-7654.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 60 units
- Distribution
- Internationally to Spain only.
- Date initiated
- 2017-11-22
- Date posted
- 2018-02-23
- Date terminated
- 2018-07-30
- Location
- Merrimack, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug (K151437) | Atrium Medical Corporation | 2015-08-27 |