Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

FDA device recall Z-1234-2023 · posted 2023-03-08 · Open, Classified

Recall details

Recalling firm

Stryker Leibinger GmbH & Co. KG

Reason for recall

Device was shipped without having regulatory approval.

Action taken

Stryker sent an Urgent Medical Device Recall letter dated December 21, 2022, to affected customers. The letter identified the affected product, problem and actions to be taken. This event is isolated to a single patient-specific product that at the time of recall notification, has already been retrieved by the recalling firm. F questions or concerns, contact Customer Service +1 800 962-6558. Please confirm the acknowledgement of this notification to CMF-custserv@stryker.com.

Root cause

No Marketing Application

Status

Open, Classified

Product code

LZD

Quantity affected

1 unit

Distribution

Distribution of one unit only to a single customer in MA (USA)

Date initiated

2022-12-06

Date posted

2023-03-08

Location

Freiburg Im Breisgau, Germany