Identity Shoulder System Resection Planer 35mm Resection Planer
FDA Recall Z-1098-2023 · Posted 2023-02-06
Recalling FirmZimmer, Inc.
Recall StatusOpen, Classified
Product CodeHTO
Date Initiated2022-12-07
Product Quantity84 units
Reason for Recall
Two planers were found to be unusable during sawbones shoulder training.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.