Recall Z-1098-2023
Zimmer, Inc. · initiated December 7, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Identity Shoulder System Resection Planer 35mm Resection Planer
Codes / lots: 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).
Reason for recall
Two planers were found to be unusable during sawbones shoulder training.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1098-2023
- Initiated
- December 7, 2022
- Posted by FDA
- February 6, 2023
- Product code
- HTO – Reamer
- Quantity
- 84 units
- Distribution
- US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
- Recalling firm
- Zimmer, Inc., Warsaw, IN