Z-1098-2023 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-1098-2023 was initiated by Zimmer, Inc. on Dec 7, 2022 and is designated Class II. Reason for recall: Two planers were found to be unusable during sawbones shoulder training. The recall status is ongoing. Affected quantity: 84 units.

Recall Details

Product Type
Devices
Report Date
Feb 15, 2023
Initiation Date
Dec 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84 units

Product Description

Identity Shoulder System Resection Planer 35mm Resection Planer

Reason for Recall

Two planers were found to be unusable during sawbones shoulder training.

Distribution Pattern

US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.

Code Information

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).

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1098-2023
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.