Z-1098-2023Class II

Identity Shoulder System Resection Planer 35mm Resection Planer

Name: Z-1098-2023 Identity Shoulder System Resection Planer 35mm Resection Planer
Creator: Zimmer, Inc.
Published: 2022-12-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-12-07 / Open, Classified / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Identity Shoulder System Resection Planer 35mm Resection Planer on 2022-12-07. FDA classified it as Class II and gives the reason as "Two planers were found to be unusable during sawbones shoulder training". 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-1098-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-02-06
Recalling firm: Zimmer GmbH
Product: Identity Shoulder System Resection Planer 35mm Resection Planer
Product code: HTO Reamer
Reason for recall: Two planers were found to be unusable during sawbones shoulder training.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignee notification was made to impacted distributors and hospitals beginning December 27, 2022. Consignees are asked to immediately check inventory and quarantine any impacted devices. Return of product is to be made to Zimmer Biomet via an Inventory Return Certification Form. This form shall be completed even if there is no impacted inventory.
Quantity in commerce: 84 units
Distribution: US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
Product codes and lots: Item Number: 1) SBHA4035; Lots: ZB7298335 (UDI: (01)00889024628052(11)220725(10)ZB7298335); ZB7234012 (UDI: (01)00889024628052(11)220512(10)ZB7234012); ZB3987432 (UDI: (01)00889024628052(11)220308(10)ZB3987432) 2) SBHA4040; Lot ZB7234013 (UDI: (01)00889024628069(11)220512(10)ZB7234013) 3) SBHA4045; Lot ZB7234014 (UDI: (01)00889024628076(11)220525(10)ZB7234014) 4) SBHA4050; Lots: ZB7234015 (UDI: (01)00889024628083(11)220624(10)ZB7234015); ZB3987435 (UDI: (01)00889024628083(11)220312(10)ZB3987435); ZB3986427 (UDI: (01)00889024628083(11)220307(10)ZB3986427) 5) SBHA4055; Lots: ZB7252285 (UDI: (01)00889024628090(11)220704(10)ZB7252285); ZB3986428 (UDI: (01)00889024628090(11)220307(10)ZB3986428); and ZB3987436 (UDI: (01)00889024628090(11)220612(10)ZB3987436).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1098-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06

Product code HTO

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)