Recalls / —
—#161830
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.
- FDA product code
- FTL — Mesh, Surgical, Polymeric
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K151437
- Affected lot / code info
- Product Code/REF 1010306-06 Lot Number/LOT: 412298
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.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Atrium Medical Corporation
- Address
- 40 Continental Blvd, Merrimack, New Hampshire 03054-4332
Distribution
- Distribution pattern
- Internationally to Spain only.
Timeline
- Recall initiated
- 2017-11-22
- Posted by FDA
- 2018-02-23
- Terminated
- 2018-07-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161830. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.