CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report
Guide Blocks for the 2 Column Plate 6 Hole Head recalled by Synthes
Synthes is recalling Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System), distributed nationwide in the US. The recall was initiated on 29 May 2014 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-2087-2014
- FDA event ID
- 68442
- Recalling firm
- Synthes, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2014
- FDA classified
- 21 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 29 May 2014 | Recall initiated by company | |
| 21 Jul 2014 | Classified by FDA | +53 days |
| 30 Jul 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Where it was distributed
Distribution US Nationwide and Bermuda.
Questions about this recall
Is Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) recalled?
Yes. Synthes recalled Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) on 29 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2087-2014.
Why was it recalled?
The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
Which lots are affected?
part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
Where was it sold?
Distribution US Nationwide and Bermuda.
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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