Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersi

FDA device recall Z-2111-2017 · posted 2017-05-15 · Terminated

Recall details

Recalling firm

Zimmer Gmbh

Reason for recall

the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.

Action taken

Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated May 11 2017. Lot Specific notifications were sent to the affected consignee via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to call Technical Services at 1-574-371-3071.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HTT

Quantity affected

138 (OUS 297)

Distribution

Single US consignee CO.

Date initiated

2017-05-11

Date posted

2017-05-15

Date terminated

2017-11-03

Location

Winterthur, Switzerland