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Terminated

Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433

FDA Recall Z-2542-2017 · Posted None

Recalling FirmMedtronic
Recall StatusTerminated
Product CodeGAM
Date Initiated2017-05-03
Date Terminated2019-07-18
Product Quantity478,465 (total for all products)

Reason for Recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Firm Action

All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.

Root Cause

Process control

Distribution Pattern

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990951MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco Healthc · 1999-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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