—#172921

Product

Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K151224
Affected lot / code info: Lot M26888

Why it was recalled

Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.

Root cause (FDA determination)

Process control

Action the firm took

On November 14, 2018, the firm sent an "Urgent Medical Device Recall" letters dated November 14, 2018, to its affected customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. Review this notification 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. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-447-3625 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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: US Distribution to CA, NC, and NY; and International to Germany.

Timeline

Recall initiated: 2018-11-14
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172921. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.