Synvasive Technology Inc: 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

Recall number

Z-0466-2016

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

Status

Terminated

Initiated

2015-12-08

Posted

not on file

Terminated

2016-11-01

Reason

Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.

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 CorporateQua1ity.PostMarket@zimmerbiomet.com. 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

14

Distribution

US Distribution to one location each in CT, MA and CA.

Lot, serial or model codes

Synvasive Part number: 11-4770; Part number: 19075127YT1;  Lot numbers: 45104 and 43054.

510(k) numbers

not on file

PMA numbers

not on file

Product code

GFA

Firm FEI

1000123893

Firm city

El Dorado Hills

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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