Identity recallZ-1098-2023 · Zimmer, Inc. · initiated Dec 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Two planers were found to be unusable during sawbones shoulder training.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1098-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2022
- Posted by the FDA
- Feb 6, 2023
- Recalling firm
- Zimmer, Inc.
- Quantity
- 84 units
- Product code
- HTO
- Distribution
- US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
Product description
Identity Shoulder System Resection Planer 35mm Resection Planer
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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).
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Identity™ SBHA4035Zimmer, Inc. · REAMER1 recall0 reports
- Identity™ SBHA4040Zimmer, Inc. · REAMER1 recall0 reports
- Identity™ SBHA4045Zimmer, Inc. · REAMER1 recall0 reports
- Identity™ SBHA4050Zimmer, Inc. · REAMER1 recall0 reports
- Identity™ SBHA4055Zimmer, Inc. · REAMER1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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