THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451

FDA device recall Z-1347-2020 · posted 2020-01-29 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

Action taken

On January 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to take the following actions: 1. Review the recall information and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. The sales representative will remove the affected product from your facility. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond the existing follow-up schedule. IF there is a device fracture, it can be detected through x-rays. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JDO

Quantity affected

1662

Distribution

Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI

Date initiated

2020-01-07

Date posted

2020-01-29

Date terminated

2021-04-08

Location

Warsaw, IN

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