Z-0466-2016Class II

Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No...

Name: Z-0466-2016 Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No...
Creator: Synvasive Technology Inc
Published: 2015-12-08
License: https://open.fda.gov/license/

Synvasive Technology, Inc. / initiated 2015-12-08 / Terminated / root cause: labeling and UDI

FDA source

Synvasive Technology Inc began a recall of Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description... on 2015-12-08. FDA classified it as Class II and gives the reason as "Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm". 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-0466-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-08
Posted: 2015-12-22
Terminated: 2016-11-01
Recalling firm: Synvasive Technology, Inc.
Product: Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Zimmer sent an Urgent Medical Device Removal letter on December 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: I. Review this notification. 2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities. 3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified. 4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday. Letters to Rick Managers are similar and the actions requested by them are: 1. Reviewing this notification and forwarding to all people within your organization that may utilize this product. 2. Identifying and quarantining the affected product to prevent further distribution or use. 3. Completing the attached Response Form and returning it via e-mail to [email protected]. Returning affected product to: Zimmer Surgical Attn: QA!RA Dept. - Recall Please include a copy of the Response Form with the shipment. 4. Upon receipt of affected product, Zimmer will credit your account for unused Zimmer Oscillating Flat Blade - TS ST Hub, 75mm x 19mm, xl.OO/l.27mm, lots 43054 and 45104 only. Please return a copy of the completed response form along with your returned product to ensure proper credit. Important: Please distribute this notification to all personnel within your organization who need to be aware. If you have further distributed affected product(s), please provide the customer 's information on the Business Response Form to Zimmer. Letters also included a FAQ sheet regarding the labeling error.
Quantity in commerce: 14
Distribution: US Distribution to one location each in CT, MA and CA.
Product codes and lots: Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0466-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0466-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22

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)