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Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral… recallZ-2254-2023 · Zimmer, Inc. · initiated Jun 27, 2023

Class II Open, Classified All recalls posted in July 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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 hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. 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 [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement .

Recall details

Recall number
Z-2254-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 27, 2023
Posted by the FDA
Jul 28, 2023
Recalling firm
Zimmer, Inc.
Quantity
75 units
Product code
HRS
FDA submissions
K141734
Distribution
AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea Netherlamds Taiwan

Product description

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

Code information (models, lots, serial numbers)

Lot Number/UDI: 64254511 /(01)0089024055940(10)64254511; 64296571/(01)0089024055940(10)64296571; 65379087/(01)0089024055940(10)65379087; 65379093/(01)0089024055940(10)65379093; 65379096/(01)0089024055940(10)65379096

Other devices under the same FDA submission

19 devices cleared under K141734 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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