Z-2732-2024Class II

Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog...

Name: Z-2732-2024 Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog...
Creator: Howmedica Osteonics Corp.
Published: 2024-08-05
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2024-08-05 / Open, Classified / root cause: manufacturing process

FDA source

Howmedica Osteonics Corp. began a recall of Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00 on 2024-08-05. FDA classified it as Class II and gives the reason as "A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2732-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-05
Posted: 2024-08-26
Recalling firm: Howmedica Osteonics Corp
Product: Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On August 5, 2024 an URGENT MEDICAL DEVICE RECALL letter was sent to their consignee. Actions Needed: Our records indicate that you have received the affected product, and that product has already been returned to Stryker. We therefore request that you read this notice carefully and complete the following actions. 1. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. We regret any inconvenience this action may cause. For questions pertaining to the recall, please email [email protected]
Quantity in commerce: 1 unit (OUS only)
Distribution: International distribution to the country of Australia.
Product codes and lots: Catalog Number: C-MM100434-00; Lot Number: HX2H9A;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2732-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2732-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-26

Product code JDI

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)