Z-1676-2020Class II

ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic...

Name: Z-1676-2020 ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic...
Creator: Synvasive Technology Inc
Published: 2018-07-27
License: https://open.fda.gov/license/

Synvasive Technology, Inc. / initiated 2018-07-27 / Terminated / root cause: labeling and UDI

FDA source

Synvasive Technology Inc began a recall of 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... on 2018-07-27. FDA classified it as Class II and gives the reason as "Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1676-2020
Classification: Class II
Status: Terminated
Initiated: 2018-07-27
Posted: 2020-04-06
Terminated: 2021-06-07
Recalling firm: Synvasive Technology, Inc.
Product: 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
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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
Quantity in commerce: 266 units
Distribution: US distribution to states of AL and NY
Product codes and lots: Lot Number/UDI: 265474 (01)00846795028320(17)220414(10)265474 304117 (01)00846795028320(17)230131(10)304117 317918 (01)00846795028320(17)230531(10)317918

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1676-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-06

Product code GFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)