Recall Z-2254-2023 ยท HRS Plate, Fixation, Bone
Zimmer, Inc.
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Item Number: 00235710106
| Date | Jul 28, 2023 (initiated Jun 27, 2023) |
| Status | Open, Classified |
| Reason | Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. |
| Root cause | Process control |
| Action | Zimmer Biomet issued Urgent Medical Device Recall Letter to Distributors/Risk Managers and Surgeons on June 27, 2023. Letter states reason for recall, health risk and action to take: 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. If the product has been further distributed, provide your customers with the recall notice for h |
| Quantity | 75 units |
| Distribution | AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea Netherlamds Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141734 | ZIMMER PERIARTICULAR LOCKING SYSTEM Zimmer, Inc., Aug 13, 2014 |