—#166235

Product

Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K081546
Affected lot / code info: Lot 969440; UDI (01)00887868012310(17)280309(10)969440

Why it was recalled

A size 22mm threaded peg was found in the package of a 10mm unit.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall " letter dated 7/12/18, to customers. The described the product, problem and actions to be taken.The letter instructed Risk Managers to perform the following actions: 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 Attachment 1 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 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. Distributors were instructed to perform the following: Your Responsibilities Review this notification and ensure that affected team members are aware of the contents. 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number through zimmerbiometintlirarequests@zimmerbiomet.com for international returns c. For each return, send a copy of Att

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: International Distribution to countries of: Japan and Netherlands.

Timeline

Recall initiated: 2018-07-12
Terminated: 2020-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.