Identity Shoulder System Resection Planer 35mm Resection Planer
FDA device recall Z-1098-2023 · posted 2023-02-06 · Open, Classified
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Two planers were found to be unusable during sawbones shoulder training.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HTO
- Quantity affected
- 84 units
- Distribution
- US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
- Date initiated
- 2022-12-07
- Date posted
- 2023-02-06
- Location
- Warsaw, IN
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