Recalls / —

—#197870

Product

Identity Shoulder System Resection Planer 35mm Resection Planer

FDA product code

HTO — Reamer

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

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).

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Zimmer, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

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

Timeline

Recall initiated

2022-12-07

Posted by FDA

2023-02-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.