Z-2703-2011

"***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi...

Name: Z-2703-2011 "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2011-01-26
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2011-01-26 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec... on 2011-01-26. The reason FDA records is "ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable...". 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-2703-2011
Status: Terminated
Initiated: 2011-01-26
Posted: 2011-06-29
Terminated: 2011-07-18
Recalling firm: Linvatec Corporation
Product: "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product. Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at [email protected].
Quantity in commerce: 45 each
Distribution: Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.
Product codes and lots: Lot 211581

Product code MBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)