Z-0180-2023Class II

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support...

Name: Z-0180-2023 Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support...
Creator: Baxter Healthcare Corporation
Published: 2022-09-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-09-20 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm... on 2022-09-20. FDA classified it as Class II and gives the reason as "the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0180-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-20
Posted: 2022-11-03
Recalling firm: Baxter Healthcare Corporation
Product: Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
FDA root cause: Other
Action: The firm issued an Urgent Medical Device Correction notice to their consignee on 09/20/2022 by email. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer: 1. Identify the impacted lot number listed on page 1 and stop any use of the product immediately. 2. Hillrom will contact you to perform a correction of your impacted device as soon as possible." The firm issued an Urgent Medical Device Recall notice to their consignees on 09/27/2022 by FedEx 2nd day delivery. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer: 1. Identify the impacted lot numbers listed in the above table and replace with the enclosed device that accompanies this notification. 2. Please return the impacted unit per RMA instructions attached within 10 business days. Actions to be taken by Distributor: 1. Please forward this notification to your end users along with replacement parts accompanying this notification. 2. Please request return of the impacted devices from your end users and return the devices to Hillrom, per RMA instructions attached." Both notices provided the following contact information: "Contact reference person If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or [email protected]"
Quantity in commerce: 1 unit
Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Product codes and lots: UDI/DI 00615521012731, Lot Number: 22-124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0180-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0175-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0176-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0177-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0178-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0179-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0180-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-11-03

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)