Z-0253-2018Class II

Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures...

Name: Z-0253-2018 Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures...
Creator: ConMed Corporation
Published: 2017-04-17
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2017-04-17 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open... on 2017-04-17. FDA classified it as Class II and gives the reason as "Manufactured with the incorrect anchor outer body". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0253-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-17
Posted: 2017-12-14
Terminated: 2021-08-31
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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Manufactured with the incorrect anchor outer body
Root cause tag: manufacturing process
FDA 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: [email protected]. Customers with questions can contact the Field Action Support Team at 1-800-237-0169.
Quantity in commerce: 56 units
Distribution: CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
Product codes and lots: Lot Number 786351

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0253-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0253-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-14

Product code MBI

K091549Class IIConmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. / cleared 2009-06-23

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)