Recall Z-2548-2019— Musculoskeletal Transplant Foundation, Inc.

Name: FDA recall Z-2548-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-15

Class II · Terminated

Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2019-08-15, terminated 2020-07-01. It names one FDA 510(k) clearance: K181633. Product: QuickGraft¿ Model # 430PST. Reason: Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure..

Recalling firm: Musculoskeletal Transplant Foundation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Terminated: 2020-07-01
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K181633 — MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation·cleared 2019-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

QuickGraft¿ Model # 430PST

Reason for recall

Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.