Z-1600-2026Class II

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation...

Name: Z-1600-2026 Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation...
Creator: I.T.S. GmbH
Published: 2026-01-23
License: https://open.fda.gov/license/

I.T.S. GmbH / initiated 2026-01-23 / Open, Classified / root cause: labeling and UDI

FDA source

I.T.S. GmbH began a recall of Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short... on 2026-01-23. FDA classified it as Class II and gives the reason as "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1600-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-23
Posted: 2026-03-20
Recalling firm: I.T.S. GmbH
Product: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: ITS initially notified its importer/distributor on about 01/23/2026 via email. Instructions were to cease distribution, and further information will be provided. An additional notification was sent to distributors and consignees on about 02/04/2026 via email. Instructions included to ensure any IFU different to the provided one is removed from systems and/or destroyed, notify clinical staff managing patients with implants, contact I.T.S. GmbH for any questions or to discuss proper scanning conditions for implanted devices in the interim while they work on labeling and IFU updates for the devices, and arrange for the return of specific originally packaged items - base plates and screws in surgery trays. Other outlined products can continue to be used upon confirmation from ITS. Consignees were also instructed to complete and return the response form. Distributors were instructed to continue to immediately halt product distribution from the U.S. office to sales groups and hospitals, remove the outdated paper IFU from packaging and add the eIFU symbol to product labeling to implement the updated IFU provided electronically - see annex "F-7.5.5-3-US_IFU_non-sterile_Rev00_DRAFT". Paper IFUs will be made available upon request. They were also requested to assist in notification of hospitals.
Quantity in commerce: 11 units
Distribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.
Product codes and lots: 1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1600-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1592-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1593-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1594-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1595-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1596-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1597-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1598-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1599-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1600-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1601-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1602-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1603-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1604-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1605-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1606-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1607-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1608-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20

Product code HRS

K063166Class III.t.s. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH / cleared 2006-12-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)