Z-1497-2014Class II

Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4...

Name: Z-1497-2014 Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4...
Creator: Teleflex Medical
Published: 2014-03-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-11 / Terminated

FDA source

Teleflex Medical began a recall of Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4... on 2014-03-11. FDA classified it as Class II and gives the reason as "The products are being recalled because they did not meet minimum diameter requirements". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1497-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-04-24
Terminated: 2015-12-17
Recalling firm: Teleflex Medical
Product: Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
Product code: GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Reason for recall: The products are being recalled because they did not meet minimum diameter requirements.
FDA root cause: Other
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected constomers. The letter identified the affected product, problem and actions to be taken. Customers were instructed if they have affected stock immediately discontinue use, quarantine, and return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgement Form and Fax it to 1-508-964-6078, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-508-964-6042.
Quantity in commerce: 3,816 ea
Distribution: Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.
Product codes and lots: Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number: 02F1101062; Product Code: EP4013P, Lot number: 02L0800898; Product Code: EP4110N, Lot number: 02H0900483; Product Code: X-2235, Lot numbers: 02E1102068, 02F1101041, 02F1201500, and 02G1201230; Product Code: X29-7271M2, Lot number: 02K1100784; Product Code: X-5667M8 and Product Code: X-6730M5, Lot number: 02G1300492.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code GAQ

K930738Class IISurgical Sutures, Pgl, Gut, Deklene, Opthamend EtcDeknatel, Inc. / cleared 1994-07-26

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)