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FDA Medical Device Recalls (openFDA)

Musculoskeletal Transplant Foundation, Inc.: QuickGraft Model # 430PST

Recall number
Z-2548-2019
Recalling firm
Musculoskeletal Transplant Foundation, Inc.
Product
QuickGraft Model # 430PST
Status
Terminated
Initiated
2019-08-15
Posted
not on file
Terminated
2020-07-01
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.
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
9 Qty
Distribution
NY NC LA TX MO OH
Lot, serial or model codes
Serial # 00319004921075 00319004921073 00319007681048 00319014411085 00618052231059 03319006511040 03319009191029 03319019231072 03519018121056
510(k) numbers
["K181633"]
PMA numbers
not on file
Product code
GAT
Firm FEI
3001236616
Firm city
Edison
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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