FDA Medical Device Recalls (openFDA)
ConMed Corporation: Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
- Recall number
- Z-0253-2018
- Recalling firm
- ConMed Corporation
- Product
- Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
- Status
- Terminated
- Initiated
- 2017-04-17
- Posted
- not on file
- Terminated
- 2021-08-31
- Reason
- Manufactured with the incorrect anchor outer body
- Root cause
- Mixed-up of materials/components
- Action
- On April 17, 2017 CONMED distributed Urgent Device Recall notices and business reply forms to customers via USPS First Class. Customers are instructed to stop use of the devices immediately and to review inventory for any of the affected product. CONMED requests that customers contact all departments within their facilities and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive the notice and respond immediately. Customers who have received affected product are expected to complete the Business Reply Form and return it with unused devices. Customers who do not have any affected devices to return are still advised to complete and return the Business Reply Form via email to: largpop@conmed.com. Customers with questions can contact the Field Action Support Team at 1-800-237-0169.
- Quantity
- 56 units
- Distribution
- CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
- Lot, serial or model codes
- Lot Number 786351
- 510(k) numbers
- ["K091549"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28