CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes recalled by Zimmer
Zimmer is recalling ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, Nonsterile- 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-1723-2024
- 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, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
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?
GTIN: 00889024055872 Lot Numbers: Lot Number 63579608 63579611 63579634 64403617 64403618 64403619 64403624 64403625 64403626 64403627 64403628 64403629 64403630 64403631 64403632 64403633 64403634 64423729 64423730 64423731 64423732 64423733 64423734 64423735 64423736 64423737 64423738 64423739 64423740 64423741 64423742 64475394 64475399 64528496 64528497 64528498 64528499 64528501 64528502 64528503 64528504 64528505 64528506 64544896 64544898 64544899 64544901 64544902 64544903 64544904 64544905 64544907 64544908 64544909 64544912 64544913 64544915 64544916 64544917 64544919 64544920 64544921 64544922 64544923 64544924 64544925 64544926 64544928 64544929 64572585 64572586 64572587 64572588 64572589 64572590 64572591 64588269 64588270 64588271 64588272 64588273 64588274 64588275 64588276 64588277 64588278 64588279 64588280 64588281 64610599 64610602 64610604 64610605 64610606 64610607 64610608 64610609 64610610 64610611 64610612 64648204 64648205 64648206 64648207 64648208 64648209 64648210 64661052 64732233 64732234 64732235 64732236 64745725 64745726 64745728 64817283 64826538 64826539 64826540 65145488 65145489 65145490 65145492 65145494 65145495 65145497 65145498 65145499 65145502 65145586 65145709 65145764 65145766 65145797 65155431 65155432 65155435 65155436 65155437 65155438 65155439 65155440 65155441 65155442 65155918 65155919 65155920 65155921 65192587 65192588 65192589 65192590 65206091 65206092 65206093 65206094 65206095 65206096 65206097 65206098 65206099 65206101 65206102 65206103 65934061 65934062 65934063 65934064 65934065 65990247 65990252 65990256 65990260 66068473 66081129 66094429 66094432 66094435 66121840 66121844 66121847 66134368 66134371 66174603 66174606 66174608 66187660 66187665 66187670 66194637 66209331 66209336 66240682 66240686 66240689
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.
More recalls from Zimmer
All 539| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Off-Axis Comprehensive Shoulder System, Large, Augment recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled | Zimmer | Packaging Defects | IN |
| Device | CLASS II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |