Device product

Identity Shoulder System Resection Planer 35mm Resection Planer

Z-1098-2023

December 07, 2022

Class II

Product summary

Firm: Zimmer, Inc.
Event: Event 91468
Status: Ongoing
Classification: Class II
Quantity: 84 units
Official record key: device-enforcement:Z-1098-2023

Official wording

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

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).

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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