—#162192

Product

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K140891
Affected lot / code info: Lot: 120910

Why it was recalled

One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

Root cause (FDA determination)

Error in labeling

Action the firm took

Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification n and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. 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 an International Return Authorization Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark "RECALL" on the outside of the returned cartons. 4. Return a copy of the your Inventory Return Certification and product return form. 5. For questions call customer service at 574-374-3071.

Recalling firm

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

Distribution

Distribution pattern: Canada.

Timeline

Recall initiated: 2017-12-07
Terminated: 2020-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162192. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.