Z-1072-2022Class II

Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is...

Name: Z-1072-2022 Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is...
Creator: Synthes (USA) Products LLC
Published: 2022-04-07
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2022-04-07 / Open, Classified / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The... on 2022-04-07. FDA classified it as Class II and gives the reason as "DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis". 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-1072-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-07
Posted: 2022-05-12
Recalling firm: Synthes (USA) Products LLC
Product: Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: DePuy Synthesis issued Urgent: MEDICAL DEVICE CORRECTION (Notification) on 4/14/22. Letter states reason for recall, health risk and action to take: " Download and review the updated version of the e-IFU from the following website: https://www.e-ifu.com/search-document-metadata/radial%20head%20replacement%20system Forward this notice to all attending surgeons in your facility using this device. " Please complete, sign, and return the Business Reply Form within three (3) business days email to [email protected] (Please reference FA 2097468 in the subject line). Note: Product is NOT being removed from the field and does not need to be returned.
Distribution: US Nationwide distribution.
Product codes and lots: All serial numbers. Material GTIN Product 03.405.000S 10886982300829 Radial Head Replacement Instr Kit; 09.405.250S 10886982300614 Rad Head w/Head 22 shaft 5.5 HH10 +0; 09.405.253S 10886982300621 Rad Head w/Head 22 shaft 5.5 HH10 +3; 09.405.256S 10886982300638 Rad Head w/Head 22 shaft 5.5 HH10 +6; 09.405.260S 10886982300645 Rad Head w/Head 22 shaft 6.5 HH10 +0; 09.405.263S 10886982300652 Rad Head w/Head 22 shaft 6.5 HH10 +3; 09.405.266S 10886982300669 Rad Head w/Head 22 shaft 6.5 HH10 +6; 09.405.270S 10886982300676 Rad Head w/Head 22 shaft 7.5 HH10 +0; 09.405.273S 10886982300683 Rad Head w/Head 22 shaft 7.5 HH10 +3; 09.405.276S 10886982300690 Rad Head w/Head 22 shaft 7.5 HH10 +6; 09.405.280S 10886982300706 Rad Head w/Head 22 shaft 8.5 HH10 +0; 09.405.283S 10886982300713 Rad Head w/Head 22 shaft 8.5 HH10 +3; 09.405.286S 10886982300720 Rad Head w/Head 22 shaft 8.5 HH10 +6; 09.405.560S 10886982300737 Rad Head w/Head 25 shaft 6.5 HH11 +0; 09.405.563S 10886982300744 Rad Head w/Head 25 shaft 6.5 HH11 +3; 09.405.566S 10886982300751 Rad Head w/Head 25 shaft 6.5 HH11 +6; 09.405.570S 10886982300768 Rad Head w/Head 25 shaft 7.5 HH11 +0; 09.405.573S 10886982300775 Rad Head w/Head 25 shaft 7.5 HH11 +3; 09.405.576S 10886982300782 Rad Head w/Head 25 shaft 7.5 HH11 +6; 09.405.580S 10886982300799 Rad Head w/Head 25 shaft 8.5 HH11 +0; 09.405.583S 10886982300805 Rad Head w/Head 25 shaft 8.5 HH11 +3; 09.405.586S 10886982300812 Rad Head w/Head 25 shaft 8.5 HH11 +6; 09.405.950S 10886982300522 Rad Head w/Head 19 shaft 5.5 HH9 +0; 09.405.953S 10886982300539 Rad Head w/Head 19 shaft 5.5 HH9 +3; 09.405.956S 10886982300546 Rad Head w/Head 19 shaft 5.5 HH9 +6; 09.405.960S 10886982300553 Rad Head w/Head 19 shaft 6.5 HH9 +0; 09.405.963S 10886982300560 Rad Head w/Head 19 shaft 6.5 HH9 +3; 09.405.966S 10886982300577 Rad Head w/Head 19 shaft 6.5 HH9 +6; 09.405.970S 10886982300584 Rad Head w/Head 19 shaft 7.5 HH9 +0; 09.405.973S 10886982300591 Rad Head w/Head 19 shaft 7.5 HH9 +3; 09.405.976S 10886982300607 Rad Head w/Head 19 shaft 7.5 HH9 +6.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1072-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1072-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12

Product code KWI

K183618Class IIRevolution Radial HeadIgnite Orthopedics, Inc. / cleared 2019-05-17

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)