Z-2261-2018Class II

P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation...

Name: Z-2261-2018 P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation...
Creator: Paragon 28, Inc.
Published: 2017-12-19
License: https://open.fda.gov/license/

Paragon 28 / initiated 2017-12-19 / Terminated / root cause: labeling and UDI

FDA source

Paragon 28, Inc. began a recall of P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation... on 2017-12-19. FDA classified it as Class II and gives the reason as "Missing drill guide as stated in the package". 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-2261-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-06-20
Terminated: 2021-01-15
Recalling firm: Paragon 28
Product: P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Product code: JDR Staple, Fixation, Bone
Reason for recall: Missing drill guide as stated in the package.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Paragon 28 Inc. sent an "MEDICAL DEVICE RECALL" letter dated Dec 19, 2017 to their consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to immediately review their inventory to determine if they have the devices; if you have possession of any of the devices, you must ship entire kit back to Paragon 28 Inc., 96 Inverness Drive, E. ste 1; Englewood CO 80112. If you have any questions, contact Senior Quality Manager at 720-643-1301 or email to: [email protected].
Quantity in commerce: 1,626
Distribution: Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.
Product codes and lots: Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-010-1010-S 10mm x 10mm x 10mm, Straight Lots 260317717A, 260317717C, 260322017B, and 260326217D., Part # P71-108-0808-S 8mm x 8mm x 8mm, Angled, Lots 260322017C, 260322017D, 260315217B, and 260326217M. and Part # P71-110-1010-S 10mm x 10mm x 10mm, Angled Lots 260326217E, 260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2261-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20

Product code JDR

K170923Class IIJAWS(TM) Nitinol Staple SystemParagon 28 / cleared 2017-07-24

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)