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U.S. Department of Health and Human Services

Class 2 Device Recall Identity Shoulder System Resection Planer

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 Class 2 Device Recall Identity Shoulder System Resection Planersee related information
Date Initiated by FirmDecember 07, 2022
Date PostedFebruary 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1098-2023
Recall Event ID 91468
Product Classification Reamer - Product Code HTO
ProductIdentity Shoulder System Resection Planer 35mm Resection Planer
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).
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Two planers were found to be unusable during sawbones shoulder training.
FDA Determined
Cause 2		Process control
ActionConsignee 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.
Quantity in Commerce84 units
DistributionUS Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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