CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes recalled by Zimmer
Zimmer is recalling ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, Sterile- Indicated for temporary, distributed nationwide in the US. The recall was initiated on 20 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1715-2024
- FDA event ID
- 94276
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Mar 2024
- FDA classified
- 30 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Mar 2024 | Recall initiated by company | |
| 30 Apr 2024 | Classified by FDA | +41 days |
| 8 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Thread form issue for the locking holes in that the locking screws may 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, may result in delay in surgery or loss of fixation resulting further intervention
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
Questions about this recall
Why was it recalled?
Thread form issue for the locking holes in that the locking screws may 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, may result in delay in surgery or loss of fixation resulting further intervention
Which lots are affected?
UDI: (01)00889024088566(17)290409(10)64325922 (01)00889024088566(17)290414(10)64325923 (01)00889024088566(17)290515(10)64396817 (01)00889024088566(17)290517(10)64396818 (01)00889024088566(17)290831(10)64464677 (01)00889024088566(17)300325(10)64714915 (01)00889024088566(17)300330(10)64714916 (01)00889024088566(17)300321(10)64714917 (01)00889024088566(17)320329(10)65324701 (01)00889024088566(17)320510(10)65387353 (01)00889024088566(17)330220(10)65716463 (01)00889024088566(17)330127(10)65716464 (01)00889024088566(17)330426(10)65982902 (01)00889024088566(17)330426(10)66010705 Lot Numbers: 64325922 64325923 64396817 64396818 64464677 64714915 64714916 64714917 65324701 65387353 65716463 65716464 65982902 66010705
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
20 other products · FDA event 94276This product is part of a recall event; the main page for the event is ZPLP(Zimmer Periarticular Locking Plate System) Distal recalled.
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