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Terminated

ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer

FDA Recall Z-1676-2020 · Posted None

Recall StatusTerminated
Product CodeGFA
Date Initiated2018-07-27
Date Terminated2021-06-07
Product Quantity266 units

Reason for Recall

Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.

Firm Action

Zimmer Biomet issued Urgent Medical Device Recall letter dated 7/27/18 stating reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your facility. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. c. Request an RGA number for each unit by calling 800-830-0970 or emailing [email protected]. d. Mark RECALL and RGA Number on the outside of the returned cartons. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-830-0970 between 8:00 am and 5:00pm EST, Monday through Friday

Root Cause

Labeling Change Control

Distribution Pattern

US distribution to states of AL and NY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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