Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or no

FDA device recall Z-2292-2016 · posted 2016-07-26 · Terminated

Recall details

Recalling firm

Zimmer Gmbh

Reason for recall

Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.

Action taken

Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 30, 2016 to all affected customers 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 were instructed to review the notification immediately and ensure affected personnel are aware of the contents and assist Zimmer Biomet sales representative with the quarantine of any affected device. Your Zimmer Biomet sales representative will remove any affected device. Customers were also instructed to complete the Certification of Acknowledgement form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with further questions or concerns were instructed to contact the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. For questions regarding this recall call 800-348-2759.

Root cause

Labeling mix-ups

Status

Terminated

Product code

LZO

Quantity affected

2

Distribution

Nationwide Distribution to OH and NM

Date initiated

2016-06-30

Date posted

2016-07-26

Date terminated

2017-03-27

Location

Winterthur, Switzerland

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