Recall Z-1009-2018
Zimmer Biomet, Inc. · initiated October 25, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
fastener, fixation, nondegradable, soft tissue
Codes / lots: Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370
Reason for recall
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
FDA-determined cause: Process control
Action taken
In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071.
Details
- Recall number
- Z-1009-2018
- Initiated
- October 25, 2017
- Terminated
- May 12, 2020
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 429 units
- Distribution
- TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN