Identity Shoulder System Resection Planer 35mm Resection Planer
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- Two planers were found to be unusable during sawbones shoulder training.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Identity Shoulder System Resection Planer 35mm Resection Planer
Product Codes/Lot Numbers:
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).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1098-2023
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.