Z-2548-2019Class II

QuickGraft Model # 430PST

Name: Z-2548-2019 QuickGraft Model # 430PST
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2019-08-15
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2019-08-15 / Terminated / root cause: labeling and UDI

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of QuickGraft Model # 430PST on 2019-08-15. FDA classified it as Class II and gives the reason as "Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2548-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Posted: 2019-09-20
Terminated: 2020-07-01
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: QuickGraft Model # 430PST
Product code: GAT Suture, Nonabsorbable, Synthetic, Polyethylene
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: You may choose to add the additional label to the unit(s), this may be completed by an appropriate Sales Representative or hospital staff. Or, you may choose to have the unit(s) returned to MTF for the labelling correction
Quantity in commerce: 9 Qty
Distribution: NY NC LA TX MO OH
Product codes and lots: Serial # 00319004921075 00319004921073 00319007681048 00319014411085 00618052231059 03319006511040 03319009191029 03319019231072 03519018121056

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2548-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2548-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-20

Product code GAT

K181633Class IIMTF Pre-Sutured TendonMusculoskeletal Transplant Foundation / cleared 2019-03-15

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)