CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
Periarticular Locking Plate System Distal Medial Humeral recalled
Zimmer is recalling Zimmer Periarticular Locking Plate System Distal Medial Humeral Locking Plate, Short, distributed nationwide in the US. The recall was initiated on 30 Jul 2013 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-2101-2013
- FDA event ID
- 65850
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2013
- FDA classified
- 27 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Jul 2013 | Recall initiated by company | |
| 27 Aug 2013 | Classified by FDA | +28 days |
| 4 Sep 2013 | 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
Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is 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.
Where it was distributed
Internationally Distributed in China only.
Questions about this recall
Is Periarticular Locking Plate System Distal Medial Humeral Locking Plate, Short Right 11 recalled?
Yes. Zimmer recalled Periarticular Locking Plate System Distal Medial Humeral Locking Plate, Short Right 11 on 30 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2101-2013.
Why was it recalled?
Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.
Which lots are affected?
Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319
Where was it sold?
Internationally Distributed in China only.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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