—#176833

Product

Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007 47492801013 47492801207 47492801213 47492801413 47492801607 47492801613 47492801702 47492801802 47492801813 47492801902 47492802002 47492802013 47493600313 47493600403 47493600407 47493600413 47493600503 47493600507 47493600513 47493600603 47493600607 47493600613 47493600703 47493600707 47493600713 47493600803 47493600807 47493600813 47493600907 47493600913 47493601003 47493601007 47493601013 47493601113 47493601203 47493601207 47493601213 47493601313 47493601403 47493601407 47493601413 47493601513 47493601607 47493601613 47493601813 47493602007 47493602013 47493602213 47493603305 47493603306 47493603405 47493603406 47493603504 47493604604 47493800303 47493800402 47493800502 47493800603 47493800613 47493800702 47493800703 47493800802 47493800803 47493800902 47494600403 47494600407 47494600413 47494600503 47494600507 47494600513 47494600603 47494600607 47494600613 47494600703 47494600707 47494600713 47494600803 47494600807 47494600813 47494600913 47494601003 47494601013 47494601113 47494601203 47494601213 47494603305 47494603306 47494603405 47494603406 47494603504 47494604604

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060710, K063303, K082527, K083654
Affected lot / code info: All product manufactured prior to January 2014.

Why it was recalled

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Root cause (FDA determination)

Packaging change control

Action the firm took

The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's 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.

Recalling firm

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

Distribution

Distribution pattern: Distributed nationwide.

Timeline

Recall initiated: 2019-10-10
Terminated: 2020-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.